Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-06-30
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Determinants of Successful Decannulation in Difficult-to-wean Patients
NCT04841889
Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit
NCT05778682
Deflating the Tracheostomy Tube Cuff and Time for Decannulation
NCT05395728
Effects of Tracheostomy Decannulation on Respiratory Function
NCT07191509
Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit
NCT01693705
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria.
2. Decannulation:
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient.
In the gradual decannulation group:
The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation.
3. Follow up:
All patients would be followed in 7, 30, 90 days following decannulation in the outpatient clinic or in their departments if still hospitalized. In these visit questionnaires regarding possible respiratory complications will be documented.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
immediate decannulation
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient
Overnight observation
patients in the immediate decannulation group would be admitted for an overnight in intensive care unit or the otolaryngology department. they would be monitored for any respiratory or airway complications.
Pre-discharge evaluation
After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.
outpatient clinic follow ups
all patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation
immediate decannulation
the tracheostomy tube is removed at once
Gradual tracheostomy tube decrease
In the gradual decannulation group The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
outpatient clinic follow ups
all patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation
Gradual tracheostomy tube decrease
The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Overnight observation
patients in the immediate decannulation group would be admitted for an overnight in intensive care unit or the otolaryngology department. they would be monitored for any respiratory or airway complications.
Pre-discharge evaluation
After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.
outpatient clinic follow ups
all patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation
immediate decannulation
the tracheostomy tube is removed at once
Gradual tracheostomy tube decrease
The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Tracheostomy tract is established more than 7 days
2. Normal vital signs: heart rate 50-100, 90\<systolic BP \<180, respiratory rate \<20. Saturation \>90% in room air
3. Effective cough
4. Normal swallows \\ feeding possibility
5. \# steps endoscopy test: through the tracheostomy tube, normal naso-laryngeal and through the tract with an upper look towards the subglottic area in order to detect subglottic stenosis.
6. Ability of the patient to breath with a capped cannula.
Exclusion Criteria
* patient with anatomical neck abnormality
* Pregnant women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soroka University Medical Center
OTHER
Kaplan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Oded Cohen
Dr Oded Cohen
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nili Segal, Dr
Role: PRINCIPAL_INVESTIGATOR
Soroka hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaplan medical center
Rehovot, Rehovot, Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82.
Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887.
Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33.
Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41.
Heffner JE. The technique of weaning from tracheostomy. Criteria for weaning; practical measures to prevent failure. J Crit Illn. 1995 Oct;10(10):729-33.
Lewarski JS. Long-term care of the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):534-7.
Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.
De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ENTK 34-CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.