Comparison Between Immediate and Gradual Decannulation

Not Applicable

• Conditions: Tracheostomy
• Interventions: Other: Overnight observation; Procedure: Gradual tracheostomy tube decrease; Other: Pre-discharge evaluation; Other: outpatient clinic follow ups; Procedure: immediate decannulation

• Registration Number: NCT02469909
• Lead Sponsor: Kaplan Medical Center

Brief Summary

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

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"

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03
• Primary Completion: 2018-06
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients who underwent tracheostomy with the following conditions:

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

• Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root)
• patient with anatomical neck abnormality
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gradual tracheostomy tube decrease	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
immediate decannulation	Pre-discharge evaluation	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
immediate decannulation	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
immediate decannulation	Overnight observation	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
immediate decannulation	outpatient clinic follow ups	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
Gradual tracheostomy tube decrease	outpatient clinic follow ups	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

Primary Outcome Measures

Name	Time	Method
re-insertion of the tracheostomy tube	7 days	number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation
mechanical ventilation	7 days	number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaplan medical center; 🇮🇱 Rehovot, Israel