[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tracheostomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tracheostomy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,46,71,99,126,157,185,209,232,254,282,300,324,344,368,393,419],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639533","predicting-the-clinical-advantages-of-speaking-valves-through-wearable-devices-100639533",false,"NCT07587762","Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices","Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study","Inclusion Criteria:\n\n* 90 years≥Age≥18 years;\n* Tracheotomy post-operation\\>48 hours；\n* Weaned off mechanical ventilation;\n* Clinically stable condition;\n* Tolerable for cuff deflation;\n* Able to tolerate wearing a speaking valve continuously for 30 minutes;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;\n* Inability to tolerate wearing a speaking valve continuously for 30 minutes;\n* Interruption of physiological monitoring data;\n* Poor quality of physiological monitoring data;\n* Recently underwent neck\u002Fupper airway surgery (≤48 hours, to avoid airflow impact on the upper airway);\n* Severe consciousness disturbance\u002Fdelirium (RASS score≤-3 or ≥ +2), extreme anxiety\u002Funcooperativeness;\n* Total laryngectomy or laryngotracheal separation;\n* Age \\\u003C18 years or \\>90 years;\n* Malignant tumor with an expected survival time ≤6 months;\n* The patient or legal representative is unable to sign the informed consent form.","ALL","18 Years","90 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.Explore the clinical benefits of the speaking valve by comparing the changes in patients' physiological parameters and clinical index metrics before and after using the speaking valve.\n\nCriteria for the successful use of the speaking valve for 30 minutes:\n\n1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.\n2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline \\\u003C 5%.\n3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.",[27,28,29],"Physiological Parameter","Wearable Devices","Tracheostomy",[31,28,32,27],"speaking valve","tracheostomy","RECRUITING","2026-05-11",{"date":36,"type":37},"2026-05-14","ACTUAL",{"date":39,"type":37},"2026-04-16",{"date":41,"type":21},"2026-12-31",{"name":43,"class":44},"Bin Zhang","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100519754","outcomes-after-tracheal-cannula-removal-100519754","NCT06047665","Outcomes After Tracheal Cannula Removal","Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study","Dekan","Inclusion Criteria:\n\n* at the time of recruitment, tracheotomized adult in-patients (≥ 18 years) of the SPC with any medical diagnosis\n* decannulated in the Swiss Paraplegic Center Nottwil within the project's data collection period\n* German, French, Italian or English as communication language\n* study consent\n\nExclusion Criteria:\n\n* patients for whom no decannulation is sought (e.g., due to degenerative illness)\n* patients for whom decannulation is planned in a clinic other than the SPC (e.g., patients hospitalized in the SPC for weaning only)",{"count":55,"type":21},150,"OBSERVATIONAL","This longitudinal observational study involves an integrated knowledge translation (IKT) approach involving key stakeholders in the project team to evaluate the tracheostomy management in patients hospitalized in the Swiss Paraplegic Centre Nottwil (SPC).",[29],[29,60,61],"Decannulation","Complications","2026-04-25",{"date":64,"type":37},"2026-04-30",{"date":66,"type":37},"2023-08-25",{"date":68,"type":21},"2026-08",{"name":70,"class":44},"Katharina Winiker",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":45},"100628864","invasive-home-ventilation-in-denmark-100628864","NCT07467187","Invasive Home Ventilation in Denmark","The Evolution of Invasive Home Mechanical Ventilation in Denmark","HOMEVENT DK","Inclusion Criteria:\n\n* Patients are included if they have or have had a respiratory certified personale care assistent during the period 2016-2025.\n\nExclusion Criteria:\n\n* Not tracheostomized\n* Tracheostomized but on spontaneous breathing throughout 1 January 2016 - 31 December 2025\n* Not discharged to home, assisted living, nursing home, or rehabilitation during 1 January 2016 - 31 December 2025",{"count":80,"type":21},450,"The aim of this study is to describe national trends over the past 10 years in patients receiving invasive home mechanical ventilation (HMV) in Denmark. This includes indications for invasive HMV, diagnostic groups, and one-year mortality.",[83,84,85,86,87,88,89,29],"Neuromuscular Diseases (NMD)","ALS (Amyotrophic Lateral Sclerosis)","Spinal Cord Injuries (SCI)","Duchenne Muscular Dystrophy (DMD)","SMA - Spinal Muscular Atrophy","MSA - Multiple System Atrophy","Tracheostomized Patients","2026-04-15",{"date":92,"type":37},"2026-04-20",{"date":94,"type":37},"2026-04-13",{"date":96,"type":21},"2028-09-01",{"name":98,"class":44},"Rigshospitalet, Denmark",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100626458","impact-of-information-and-participation-on-decision-time-for-tracheostomy-or-peg-in-icu-families-100626458","NCT07435896","Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families","Impact of Information and Participation Strategies on Decision Time for Tracheostomy or PEG Among Family Members of Intensive Care Patients","Inclusion Criteria:\n\n* First-degree relative of an ICU patient with an indication for tracheostomy and\u002For percutaneous endoscopic gastrostomy (PEG)\n* Age ≥ 18 years\n* Able to understand and communicate in Turkish\n* Provides written informed consent\n* Responsible for or involved in the medical decision-making process\n\nExclusion Criteria:\n\n* Cognitive impairment or psychiatric condition interfering with questionnaire completion\n* Refusal to participate\n* Prior participation in this study\n* Inability to complete study questionnaires",true,{"count":108,"type":21},60,"Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Inadequate or non-tailored information may negatively influence anxiety levels, decision satisfaction, and subsequent adaptation to care responsibilities. Differences in communication patterns and educational background may further affect how families perceive the risks, benefits, and long-term implications of these procedures.\n\nThis prospective study aims to evaluate the impact of relatives' educational level and different information delivery methods on anxiety, decision satisfaction, and the overall decision-making process related to tracheostomy and PEG in the ICU setting. The findings are expected to contribute to the development of structured, education-level-tailored information strategies to improve shared decision-making and family-centered care in critical care practice.",[111,29,112],"Intensive Care Unit (ICU) Admission","Percutaneous Endoscopic Gastrostomy (PEG)",[114,29,115],"Percutaneous Endoscopic Gastrostomy","Intensive Care Unit","NOT_YET_RECRUITING","2026-02-21",{"date":119,"type":37},"2026-02-27",{"date":121,"type":21},"2026-03-15",{"date":123,"type":21},"2026-06-15",{"name":125,"class":44},"Elazıg Fethi Sekin Sehir Hastanesi",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":132,"targetDuration":134,"studyType":56,"phases":4,"briefSummary":135,"conditions":136,"keywords":142,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":45},"100602285","airway-complications-in-pediatric-patients-with-tracheostomies-to-what-extent-can-symptoms-identified-by-caregivers-or-pediatricians-serve-as-predictors-for-airway-complications-confirmed-through-surveillance-endoscopy-100602285","NCT07121517","\"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?\"","Inclusion Criteria:\n\nAll children, with tracheostomy, under the age of 18, undergoing scheduled surveillance airway endoscopy in anaesthesia as part of their regular follow-up at the Long term Intensive Care unit (LIVA) at Karolinska University Hospital are eligible for inclusion. Patients may be included several times during the study period.\n\nExclusion criteria:\n\nAll patients undergoing airway endoscopy that is not part of the surveillance airway endoscopy program will be excluded. Thus, emergency endoscopies are not included in this study.",{"count":133,"type":21},100,"2 Years","Study Objective:\n\nThis observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications.\n\nStudy Population:\n\nThe study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden.\n\nResearch Questions:\n\n1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?\n2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications?\n\nMethods:\n\nChildren scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication.\n\nAfter the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol.\n\nThe airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician.",[137,138,139,140,29,141],"Surveillance","Endoscopy","Tracheostomy Complication","Tracheostomy Complications","Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter",[143,144,145,146,147],"surveillance","endoscopy","pediatric","intensive care unit","tracheostomy complication","2026-02-12",{"date":150,"type":37},"2026-02-17",{"date":152,"type":37},"2025-09-01",{"date":154,"type":21},"2027-08-31",{"name":156,"class":44},"Karolinska Institutet",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":163,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":165,"conditions":166,"keywords":171,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100584753","feeding-difficulties-and-quality-of-life-in-children-with-tracheal-cannula-100584753","NCT06893458","Feeding Difficulties and Quality of Life in Children With Tracheal Cannula","Inclusion Criteria: Children below the age of 18 with tracheostomy undergoing follow-up through the Long term Intensive Care Unit at Karolinska University Hospital in Stockholm Sweden between march 2025 and march 2027.\n\nExclusion criteria: Patients that can not undergo full evaluations\u002Fexaminations will not be included.",{"count":164,"type":21},80,"The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula.\n\nThe main questions it aims to answer are\n\n1. What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children?\n2. How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL?\n3. Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula?\n\nQuality of life will be assessed in an interview using the PedsQL instrument generic module 4.0. Swallowing difficulties will be assessed through evaluations based on The Montreal Children's Hospital Feeding Scale.",[167,29,141,168,169,170],"Quality of Life (QOL)","Feeding Difficulties","Swallowing Difficulties","Caregiver Quality of Life",[172,173,174,175,176],"pediatric quality of life","caregiver quality of life","swallowing related quality of life","feeding difficulties","pediatric tracheostomy",{"date":178,"type":37},"2026-02-13",{"date":180,"type":37},"2025-03-17",{"date":182,"type":21},"2027-03-17",{"name":156,"class":44},2,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100617374","cough-flow-as-a-criterion-decannulation-threshold-in-prolonged-tracheostomy-patients-100617374","NCT07317791","Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients","Multicenter Prospective Validation of Cough Flow With Tracheostomy Tube and Speaking Valve (CFsv) >100 L\u002FMin as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients","Inclusion Criteria:\n\n* Age ≥18 years\n* Tracheostomy tube in place for ≥14 days\n* Weaned from ventilator for more than 48 hours, or in a state of spontaneous breathing\n* Patient and family members have provided informed consent\n\nExclusion Criteria:\n\n* Severe craniofacial deformity preventing CFsv measurement\n* Known obstructive upper airway pathology precluding tracheostomy tube removal\n* Laryngopharyngeal trauma\n* Inability to tolerate cuff deflation",{"count":193,"type":21},500,[24],"Background: International studies have proposed a cough peak flow (CPF) of ≥160 L\u002Fmin as a reference threshold for safe decannulation. However, this measurement requires prior removal of the tracheostomy tube, which is often difficult for Chinese patients and their families to accept due to cultural and safety concerns. Additionally, there is a lack of rapid, user-friendly, and widely applicable quantitative tools in clinical practice within ICUs or rehabilitation specialties in China. Moreover, the heterogeneity among domestic patient populations with different underlying conditions (such as neuromuscular diseases, spinal cord injuries, stroke, and respiratory failure) makes it challenging to apply a single foreign-derived indicator. In our center's prospective study from 2019 to 2022(Respiratory Research 2024;25:128), the investigators proposed and preliminarily validated that a cough flow measured with tracheostomy tube and speaking valve (CFSV) \\>100 L\u002Fmin could serve as a threshold for safe decannulation. Among 193 patients with long-term tracheostomy tubes, 105 were decannulated based on this threshold, with a success rate of 98.1%. Only two cases required reintubation within 48 hours (1.9%), and the six-month reintubation rate was 2.9%, which is significantly better than previously reported domestic and international data (reintubation rates of 5-15%). For patients with insufficient CFSV, after an average of 26 days of individualized cough enhancement rehabilitation, 91% achieved the threshold and ultimately succeeded in decannulation. This suggests that 100 L\u002Fmin may be a more physiologically appropriate threshold for Chinese (and even East Asian) populations with indwelling tracheostomy tubes, and that CFSV combined with systematic rehabilitation interventions can significantly improve decannulation rates. However, these conclusions are derived from single-center data with a limited sample size, and the diversity of diseases and regional variations in medical standards may affect generalizability. Therefore, there is an urgent need for multicenter, large-sample prospective studies to validate the effectiveness, accuracy, and feasibility of CFSV \\>100 L\u002Fmin as a quantitative standard for safe decannulation.",[29],[60,198],"Cough peak flow","2026-01-17",{"date":201,"type":37},"2026-01-21",{"date":203,"type":21},"2026-01-01",{"date":205,"type":21},"2027-09-30",{"name":207,"class":44},"Hongying Jiang, MD",5,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":208},"100601188","sv-with-ttpee-measurement-predicts-upper-airway-patency-in-prolonged-tracheostomy-patients-100601188","NCT07107243","SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients","Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study","Inclusion Criteria:\n\n* Weaned from ventilator more than 48 hours\n* No any organ failure\n* No sepsis\n* Stable heart rate and blood pressure\n* Lung infection under control\n* PCO2\\\u003C60mmHg\n* Patient and family sign informed consent form\n\nExclusion Criteria:\n\n* Serious dysfunction of vital organs\n* Inability to tolerate cuff deflation\n* Laryngopharyngeal trauma\n* Known severe upper airway obstruction before referrer to our department\n* Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known",{"count":217,"type":21},300,[24],"The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.",[29],[222,31,223,224],"transtracheal end-expiratory pressure","upper airway","prolonged tracheostomized patients",{"date":201,"type":37},{"date":227,"type":37},"2025-10-01",{"date":229,"type":21},"2026-10-31",{"name":231,"class":44},"Capital Medical University",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":184},"100544936","digital-health-pathway-for-children-with-medical-complexity-requiring-tracheostomy-100544936","NCT06375369","Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy","Adoption and Enhancement of a Care Pathway for Children With Medical Complexity: an Implementation Evaluation Project for Tracheostomy in Pediatrics","DECIDE-T","Inclusion Criteria:\n\n* Age \\\u003C 18 years\n* First tracheostomy placement\n\nExclusion Criteria:\n\n\\-",{"count":241,"type":21},180,[24],"The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy\u002FLTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program.\n\nThe goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy\u002FLTV, as well as to decrease mental distress and burnout experienced by their caregivers and families.",[29],"2026-01-05",{"date":247,"type":37},"2026-01-06",{"date":249,"type":37},"2024-09-01",{"date":251,"type":21},"2027-12-31",{"name":253,"class":44},"University of Alberta",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":260,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":280,"locationsCount":45},"100609114","the-effects-of-listening-to-fairy-tales-listening-to-fairy-tales-in-their-mothers-voices-and-watching-cartoons-on-pain-comfort-levels-and-physiological-parameters-during-tracheostomy-care-in-a-palliative-care-clinic-100609114","NCT07210346","The Effects of Listening to Fairy Tales, Listening to Fairy Tales in Their Mothers' Voices, and Watching Cartoons on Pain, Comfort Levels, and Physiological Parameters During Tracheostomy Care in a Palliative Care Clinic","Inclusion Criteria:\n\n* Being in the 1-7 year old age group,\n* Being inpatient in a pediatric palliative care unit,\n* Having no visual or hearing abnormalities,\n* Having a tracheostomy.\n\nExclusion Criteria:\n\n* The family's desire to withdraw from the study,\n* The child's health condition deteriorates.","1 Year","7 Years",{"count":5,"type":21},[24],"This study aimed to determine the effects of listening to fairy tales, listening to fairy tales from the mother's voice, and watching cartoons on pain, comfort, and physiological parameters during tracheostomy care of children receiving palliative care.",[29,266],"Care",[268,269,270,271,272,273],"Palliative care","Children","Listening to stories","Watching Cartoons","Pain","Comfort","2025-09-29",{"date":276,"type":37},"2025-10-07",{"date":278,"type":21},"2025-11-01",{"date":203,"type":21},{"name":281,"class":44},"Ataturk University",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":45},"100525365","investigation-of-a-3-oz-water-protocol-on-patients-with-tracheostomies-100525365","NCT06120790","Investigation of a 3 oz Water Protocol on Patients With Tracheostomies","Inclusion Criteria:\n\n* Has a tracheostomy\n* Able to remain alert for testing\n* Not on a modified diet for pre-existing dysphagia\n* No head of bed restrictions\n* Not NPO by physician for any reason other than possible dysphagia\n* At least 18 years old\n\nExclusion Criteria:\n\n* Does not have a tracheostomy\n* Unable to remain alert for testing\n* On a modified diet due to pre-existing dysphagia\n* Head of bed restrictions for greater than or equal to 30 degrees\n* NPO by physician for reasons other than possible dysphagia\n* Less than 18 years old",{"count":164,"type":21},"Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study).",[29],"2025-09-05",{"date":293,"type":37},"2025-09-08",{"date":295,"type":37},"2024-05-06",{"date":297,"type":21},"2027-10",{"name":299,"class":44},"Icahn School of Medicine at Mount Sinai",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":45},"100556493","lets-eat-eating-with-assistive-technology-an-intervention-to-support-children-with-feeding-tubes-and-tracheostomies-100556493","NCT06525818","Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies","Inclusion Criteria:\n\n* Under 3 years of age\n* Reside at a family home\n* Have a gastrostomy feeding tube\n* Have a tracheostomy\n* Live within a 1-hour radius of the University of Chicago\n\nExclusion Criteria:\n\n• Wards of the state","3 Years",{"count":308,"type":21},40,[24],"The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person\u002Fvirtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech\u002Flanguage pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims:\n\nSpecific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention.\n\nSpecific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention.\n\nThe investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist.\n\nThe weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.",[312,313,29,314],"Feeding Tube","Children With Medical Complexity","Feeding Disorder, Infancy or Early Childhood","2025-08-11",{"date":317,"type":37},"2025-08-12",{"date":319,"type":37},"2024-07-08",{"date":321,"type":21},"2027-07-07",{"name":323,"class":44},"University of Chicago",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":45},"100476291","speaking-valve-influence-on-breathing-swallowing-and-vocal-functions-in-patients-with-tracheostomy-100476291","NCT05482022","Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.","Inclusion Criteria:\n\n* brain injury (traumatic\u002Fnon-traumatic).\n* tracheostomy.\n* unresponsive wakefulness syndrome or minimally conscious state.\n* fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.\n* the legal guardian speaks Hebrew.\n\nExclusion Criteria:\n\n* airway stenosis \u002F inflammation.\n* oxygen saturation \\\u003C90%.",{"count":331,"type":21},30,[24],"Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.\n\nThe investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.",[29],"2025-08-10",{"date":337,"type":37},"2025-08-14",{"date":339,"type":37},"2022-08-01",{"date":341,"type":21},"2026-01-15",{"name":343,"class":44},"Loewenstein Hospital",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100597674","objective-evaluation-of-cough-effort-in-tracheotomized-patients-lost-study-100597674","NCT07061561","Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)","Inclusion Criteria:\n\n* Adult patients (18 years or older)\n* Hospitalized in post-intensive care rehabilitation unit (SRPR) or intensive care unit (ICU)\n* Tracheotomized during the weaning process\n* Medical prescription for physiotherapy assessment\n* Medical prescription for speech therapy assessment\n\nExclusion Criteria:\n\n* Patients who have undergone total laryngectomy\n* Patients with severe swallowing disorders\n* Patients with cognitive impairments incompatible with understanding instructions\n* Patients under medical decision to stop active treatments\n* Patients who refuse to participate or refuse to sign informed consent\n* Patients under guardianship or curatorship\n* Patients not affiliated with a social security scheme",{"count":351,"type":21},34,[24],"This study aims to evaluate how well tracheotomized patients can cough before and after their tracheostomy tube is removed. Cough strength is measured using two different tools-Peak Flow and Lorio. Researchers want to find out if the cough measurement taken before removing the tube can help predict how effective the patient's cough will be afterward. The study will also explore factors that might influence cough strength and compare the usefulness of the two tools. Additionally, it will assess how patients feel about using these devices and the role of diaphragm ultrasound in predicting cough effectiveness.",[29,355,356,357,358],"Cough","Weaning","Respiratory Function Tests","Diaphragm","2025-07-02",{"date":361,"type":37},"2025-07-11",{"date":363,"type":21},"2025-07-15",{"date":365,"type":21},"2026-11-15",{"name":367,"class":44},"Centre Hospitalier de Saint-Denis",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":45},"100578857","comparison-of-physiological-effects-of-two-types-of-high-flow-oxygen-therapy-in-tracheostomized-patients-100578857","NCT06816745","Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients","Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients","Inclusion Criteria:\n\nTracheostomy with stable spontaneous breathing.\n\nExclusion Criteria:\n\n1. Age younger than 18 years old\n2. Pregnancy\n3. Hemodynamic instability (mean arterial pressure \\\u003C60 mmHg, heart rate \\>140 or \\\u003C60 bpm)\n4. Respiratory and oxygenation instability (respiratory rate \\> 35bpm or oxygen saturation measured by pulse oximetry \\\u003C90%)\n5. Neuromuscular diseases or phrenic nerve injury\n6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach\n7. Pneumothorax or placement of a chest drainage\n8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)\n9. Anticipating withdrawal of life support",{"count":376,"type":21},20,[24],"High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.",[380,381,29],"Critical Care","Oxygen Therapy",[383,32],"high-flow tracheal oxygen","2025-02-06",{"date":386,"type":37},"2025-02-10",{"date":388,"type":21},"2025-02-20",{"date":390,"type":21},"2025-12-30",{"name":392,"class":44},"Jian-Xin Zhou",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":45},"100412239","primary-vs-secondary-closure-of-tracheo-cutaneous-fistulas-100412239","NCT04647968","Primary vs Secondary Closure of Tracheo-cutaneous Fistulas","Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study","TRACH","Inclusion Criteria:\n\n* Being covered by the RAMQ\n* Having a tracheostomy either percutaneous or surgical\n* Being ready for canula removal and closure of the fistula\n\nExclusion Criteria:\n\n* Presenting a contraindication to primary tracheotomy closure (granuloma)\n* Unable to consent\n* Refusal to participate",{"count":402,"type":21},44,[24],"The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.",[139,406,29],"Post Tracheostomy Complications",[32,408,409],"tracheostomy closure","tracheocutaneous fistula","2024-07-22",{"date":412,"type":37},"2024-07-23",{"date":414,"type":37},"2021-01-12",{"date":416,"type":21},"2026-07",{"name":418,"class":44},"Université de Sherbrooke",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":184},"100534262","tracheostomy-robotics-and-cutting-edge-health-education-for-airway-safety-100534262","NCT06236542","Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety","NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care","TRACHEAS","Inclusion Criteria:\n\n* adult patients 18 years or older\n* those who received a tracheostomy during their hospital stay\n* those who were admitted to the hospital with a tracheostomy\n\nExclusion Criteria:\n\n* none","100 Years",{"count":429,"type":21},632,[24],"The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are:\n\n* What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group?\n* What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group?\n* What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group?\n* What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions.\n\n  1. Experimental group 1 will receive suctionings using automated robotic suctioning device.\n  2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.\n  3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system.\n  4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.",[29],[29,434,435,436,437,438,439,440,441,442,443],"Tracheostomy education","Immersive learning","Simulation","Virtual reality","Mixed reality","Robotics","Tracheostomy suctioning","Tracheostomy tube change","Patient safety","Critical care","2024-01-24",{"date":446,"type":37},"2024-02-01",{"date":448,"type":21},"2027-10-01",{"date":450,"type":21},"2029-09-30",{"name":452,"class":44},"Johns Hopkins University"]