Comparison Between Immediate and Gradual Decannulation

Study Overview
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Brief Summary
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The investigators propose to examine the feasibility and safety of immediate (single stage) decannulation in adult patients in a controlled randomized trial. Patients who will be found fit for decannulation after an otolaryngologist and intensive care specialist assessment will be randomized into two groups: immediate decannulation and gradual decrease in cannula size. Both groups of patients will be monitored after decannulation and in the outpatient clinic for any complications following the procedure.

Detailed Description
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Recruitment of the patients will be demands for decannulation evaluation of different departments in our institution. All patients who will agree to participate in the study and meet the inclusion criteria would undergo three major steps Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria. 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. 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.

Official Title
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Feasibility and Safety of Immediate Versus Gradual Decannulation: a Randomised Control Trial

Conditions
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Tracheostomy

Intervention / Treatment
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* Other: Overnight observation
* Other: Pre-discharge evaluation
* Other: outpatient clinic follow ups
* Procedure: immediate decannulation
* Procedure: Gradual tracheostomy tube decrease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent tracheostomy with the following conditions: Tracheostomy tract is established more than 7 days Normal vital signs: heart rate 50-100, 90<systolic BP <180, respiratory rate <20. Saturation >90% in room air Effective cough Normal swallows \ feeding possibility # 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. Ability of the patient to breath with a capped cannula. Exclusion Criteria: Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root) patient with anatomical neck abnormality Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: immediate decannulation<br>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 | Other: Overnight observation<br>* 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.<br>Other: Pre-discharge evaluation<br>* After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.<br>Other: outpatient clinic follow ups<br>* 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<br>Procedure: immediate decannulation<br>* the tracheostomy tube is removed at once<br>|
| Other: Gradual tracheostomy tube decrease<br>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 | Other: outpatient clinic follow ups<br>* 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<br>Procedure: Gradual tracheostomy tube decrease<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-insertion of the tracheostomy tube | number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation | 7 days | 
| mechanical ventilation | number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause | number of patients who died from any cause within 90 days of decannulation | 90 days | 
| Respiratory distress | number of patients who reported difficulty breathing suggestive of stridor or by examination or intervention within 90 days of decannulation | up to 90 fays following decannulation | 
| Pneumonia | number of patients who had a diagnosis of pneumonia in the period of 90 days following decannulation | 90 days following decannulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decannulation, tracheostomy