Comparison Between Immediate and Gradual Decannulation

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

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.

Study Overview

• Status: Unknown
• Conditions: Tracheostomy
• Intervention / Treatment: Other: Overnight observation; Other: Pre-discharge evaluation; Other: outpatient clinic follow ups; Procedure: immediate decannulation; Procedure: Gradual tracheostomy tube decrease

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oded Cohen, Dr; Phone Number: +972-544682490; Email: oded915@gmail.com
• Study Contact Backup: Name: Yaara Haimovich; Phone Number: +972-52-8580806; Email: yaaraha@clalit.org.il

Study Locations

• Israel
  • Rehovot, Israel
    • Recruiting
    • Kaplan Medical Center
    • Contact: Oded Cohen, Dr; Phone Number: +972-54-468-2490; Email: odedco@clalit.org.il
    • Contact: Yaara Haimovich; Phone Number: +972-528580806; Email: yaaraha@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	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
Other: 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	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: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaplan Medical Center
• Collaborators: Soroka University Medical Center
• Investigators: Principal Investigator: Nili Segal, Dr, Soroka Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: tracheostomy; Decannulation
• Other Study ID Numbers: ENTK 34-CTIL