Comparison Between Immediate and Gradual Decannulation

Tracheostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469909
• Other study ID #: ENTK 34-CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: February 28, 2017
• Start date: June 2015
• Est. completion date: January 2019

Study information

• Verified date: February 2017
• Source: Kaplan Medical Center
• Contact: Oded Cohen, Dr
• Phone: +972-544682490
• Email: oded915[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy

Intervention

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.
• 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

Procedure:
• 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

Locations

Country	Name	City	State
Israel	Kaplan medical center	Rehovot

Sponsors (2)

Lead Sponsor	Collaborator
Kaplan Medical Center	Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (8)

Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41. Review. — View Citation

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. 20 — View Citation

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. Review. — View Citation

Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82. Review. — View Citation

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. — View Citation

Lewarski JS. Long-term care of the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):534-7. Review. — View Citation

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. — View Citation

Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	mechanical ventilation	number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation	7 days
Secondary	Death from any cause	number of patients who died from any cause within 90 days of decannulation	90 days
Secondary	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
Secondary	Pneumonia	number of patients who had a diagnosis of pneumonia in the period of 90 days following decannulation	90 days following decannulation