[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tracheostomy-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tracheostomy-complication":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,80,100,127,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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",false,"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.","ALL","18 Years",{"count":18,"type":19},100,"ESTIMATED","2 Years","OBSERVATIONAL","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.",[24,25,26,27,28,29],"Surveillance","Endoscopy","Tracheostomy Complication","Tracheostomy Complications","Tracheostomy","Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter",[31,32,33,34,35],"surveillance","endoscopy","pediatric","intensive care unit","tracheostomy complication","RECRUITING","2026-02-12",{"date":39,"type":40},"2026-02-17","ACTUAL",{"date":42,"type":40},"2025-09-01",{"date":44,"type":19},"2027-08-31",{"name":46,"class":47},"Karolinska Institutet","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100508903","push-it-continuing-enteral-feeds-for-tracheostomy-100508903","NCT05906472","PUSH-IT Continuing Enteral Feeds for Tracheostomy","Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)","Inclusion Criteria:\n\n* 18 years or older\n* admitted to the intensive care unit (ICU)\n* intubated and require tracheostomy\n\nExclusion Criteria:\n\n* under 18 years\n* unable to obtain informed consent\n* deemed clinically brain dead within 7 days of enrollment\n* transitioned to comfort measures within 7 days of enrollment\n* Pregnant patients\n* Prisoners",{"count":57,"type":19},200,"INTERVENTIONAL",[60],"NA","The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are:\n\n* Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake?\n* Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections?\n\nResearchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.",[26,63,64],"Critical Illness","Nutritional Deficiency",[66,67,68,69,70],"tube feed","nil per os","aspiration","pneumonia","nutritional delivery","2025-10-16",{"date":73,"type":40},"2025-10-20",{"date":75,"type":40},"2023-02-06",{"date":77,"type":19},"2026-12-31",{"name":79,"class":47},"State University of New York at Buffalo",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":48},"100577970","increased-body-temperature-post-tracheostomy-a-retrospective-study-100577970","NCT06805214","Increased Body Temperature Post Tracheostomy: a Retrospective Study","Inclusion Criteria: Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission -\n\nExclusion Criteria: Patients who did not fullfil the above criteria\n\n\\-","99 Years",{"count":88,"type":19},400,"Tracheostomy is one of the most common procedures in intensive care units. Post-tracheostomy increased body temperature within 24 hours is common. However, frequently sepsis workup is performed along with initiation of broad spectrum antibiotic therapy. We will investigate the incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not. The study is retrospective and will be based on data collection.",[26],"2025-05-07",{"date":93,"type":40},"2025-05-11",{"date":95,"type":40},"2025-05-01",{"date":97,"type":19},"2028-03-01",{"name":99,"class":47},"Meir Medical Center",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":58,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":48},"100568681","assessment-of-the-effect-of-an-inspiratory-muscle-training-regimen-on-decannulation-time-in-tracheostomized-subjects-100568681","NCT06684392","Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects","Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation","Inclusion Criteria:\n\n* Critically ill patients aged ≥ 18 years\n* Connected to mechanical ventilation\n* Secondary tracheostomy due to prolonged mechanical ventilation\n* Glasgow Coma Scale (GCS) \\> 11 points\n* Level of cooperation score (S5Q) \\> 3 points\n\nExclusion Criteria:\n\n* Limitation of therapeutic effort (LTE\\*)\n* Pregnancy\n* Transfer to another center before completing the training (2 weeks)\n* Degenerative neuromuscular disease\n* Refusal to participate in this study (declining to provide informed consent \\[IC\\]).",{"count":108,"type":19},56,[60],"The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.",[26,112],"Diaphragm Disease",[114,115,116,117],"tracheostomy","inspiratory muscle training","diaphragm dysfunction","diaphragm ultrasound","2024-11-11",{"date":120,"type":40},"2024-11-12",{"date":122,"type":40},"2023-11-01",{"date":124,"type":19},"2025-11-01",{"name":126,"class":47},"Hospital Dr. Franco Ravera Zunino",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":48},"100558558","risk-factors-for-neck-phlegmon-after-percutaneous-tracheostomy-in-icu-100558558","NCT06552676","riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU","Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU","SORCERER","Inclusion Criteria:\n\n* Age greater than 18 years\n* Presence of indication for tracheostomy\n\nExclusion Criteria:\n\n* Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy",{"count":136,"type":19},300,"Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy.\n\nParticipant Population\u002FPrimary Condition: Patients admitted to Intensive Care\n\nMain Questions Aims to Answer:\n\n1. \\- What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?\n2. \\- How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?\n\nParticipants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons.\n\nAt the two-year follow-up, the health-related quality of life will be assessed",[26,139],"Quality of Life","2024-08-10",{"date":142,"type":40},"2024-08-14",{"date":144,"type":40},"2018-08-09",{"date":146,"type":19},"2025-01-31",{"name":148,"class":149},"Azienda Usl di Bologna","OTHER_GOV",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":58,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":48},"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",true,{"count":160,"type":19},44,[60],"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.",[26,164,28],"Post Tracheostomy Complications",[114,166,167],"tracheostomy closure","tracheocutaneous fistula","2024-07-22",{"date":170,"type":40},"2024-07-23",{"date":172,"type":40},"2021-01-12",{"date":174,"type":19},"2026-07",{"name":176,"class":47},"Université de Sherbrooke"]