NCT02469909

Comparison Between Immediate and Gradual Decannulation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kaplan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheostomy

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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
PROCEDURE	immediate decannulation	the tracheostomy tube is removed at once
PROCEDURE	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

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2019-01-01
• First posted: 2015-06-12
• Last updated: 2017-03-03

Locations

1 site across 1 country: Israel