Tracheostomy

17

Review clinical trials related to Tracheostomy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices

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. Criteria for the successful use of the speaking valve for 30 minutes: 1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc. 2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline \< 5%. 3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.

Participants needed: 120
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Bin ZhangUpdated: May 14, 2026Locations: 1
Eligibility criteria

90 years≥Age≥18 years; [+6]

Patients with abnormal skin conditions preventing continuous wearing of monitori... [+9]

Status: Recruiting

Outcomes After Tracheal Cannula Removal

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).

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Katharina WinikerUpdated: Apr 30, 2026Locations: 1
Eligibility criteria

at the time of recruitment, tracheotomized adult in-patients (≥ 18 years) of the... [+3]

patients for whom no decannulation is sought (e.g., due to degenerative illness) [+1]

Status: Recruiting

Invasive Home Ventilation in Denmark

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.

Participants needed: 450
Trial details
Biological sex: AllType: ObservationalSponsor: Rigshospitalet, DenmarkUpdated: Apr 20, 2026Locations: 1
Eligibility criteria

Patients are included if they have or have had a respiratory certified personale...

Not tracheostomized [+2]

Status: Not yet recruiting

Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families

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. This 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.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Elazıg Fethi Sekin Sehir HastanesiUpdated: Feb 27, 2026
Eligibility criteria

First-degree relative of an ICU patient with an indication for tracheostomy and/... [+4]

Cognitive impairment or psychiatric condition interfering with questionnaire com... [+3]

Status: Recruiting

"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?"

Study Objective: This 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. Study Population: The 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. Research Questions: 1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy? 2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications? Methods: Children 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. After 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. The 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.

Participants needed: 100
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Feb 17, 2026Locations: 1Duration: 2 Years
Eligibility criteria

Not listed

Status: Recruiting

Feeding Difficulties and Quality of Life in Children With Tracheal Cannula

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. The main questions it aims to answer are 1. What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children? 2. How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL? 3. Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula? Quality 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.

Participants needed: 80
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Feb 13, 2026Locations: 2
Eligibility criteria

Not listed

Status: Not yet recruiting

Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

Background: International studies have proposed a cough peak flow (CPF) of ≥160 L/min 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/min 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/min 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/min as a quantitative standard for safe decannulation.

Participants needed: 500
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Hongying Jiang, MDUpdated: Jan 21, 2026Locations: 5
Eligibility criteria

Age ≥18 years [+3]

Severe craniofacial deformity preventing CFsv measurement [+3]

Status: Recruiting

SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients

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.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Capital Medical UniversityUpdated: Jan 21, 2026Locations: 5
Eligibility criteria

Weaned from ventilator more than 48 hours [+6]

Serious dysfunction of vital organs [+4]

Status: Recruiting

Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy

The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). 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. The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families.

Participants needed: 180
Trial details
Age: Up to 18Biological sex: AllType: InterventionalSponsor: University of AlbertaUpdated: Jan 6, 2026Locations: 2
Eligibility criteria

Age < 18 years [+1]

Status: Not yet recruiting

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

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.

Participants needed: 17
Trial details
Age: 1-7Biological sex: AllType: InterventionalSponsor: Ataturk UniversityUpdated: Oct 7, 2025Locations: 1
Eligibility criteria

Being in the 1-7 year old age group, [+3]

The family's desire to withdraw from the study, [+1]

Status: Recruiting

Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

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).

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Icahn School of Medicine at Mount SinaiUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Has a tracheostomy [+5]

Does not have a tracheostomy [+5]

Status: Recruiting

Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies

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/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language 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: Specific 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. Specific 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. The 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. The 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.

Participants needed: 40
Trial details
Age: Up to 3Biological sex: AllType: InterventionalSponsor: University of ChicagoUpdated: Aug 12, 2025Locations: 1
Eligibility criteria

Under 3 years of age [+4]

Status: Recruiting

Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy. The 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.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Loewenstein HospitalUpdated: Aug 14, 2025Locations: 1
Eligibility criteria

brain injury (traumatic/non-traumatic). [+4]

airway stenosis / inflammation. [+1]

Status: Not yet recruiting

Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)

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.

Participants needed: 34
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier de Saint-DenisUpdated: Jul 11, 2025
Eligibility criteria

Adult patients (18 years or older) [+4]

Patients who have undergone total laryngectomy [+6]

Status: Not yet recruiting

Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

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.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Jian-Xin ZhouUpdated: Feb 10, 2025Locations: 1
Eligibility criteria

Age younger than 18 years old [+8]

Status: Recruiting

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

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.

Participants needed: 44
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Université de SherbrookeUpdated: Jul 23, 2024Locations: 1
Eligibility criteria

Being covered by the RAMQ [+2]

Presenting a contraindication to primary tracheotomy closure (granuloma) [+2]

Status: Not yet recruiting

Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

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: * 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? * 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? * 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? * 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. 1. Experimental group 1 will receive suctionings using automated robotic suctioning device. 2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system. 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. 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.

Participants needed: 632
Trial details
Age: 18-100Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Feb 1, 2024Locations: 2
Eligibility criteria

adult patients 18 years or older [+2]

none