Clinical trial NCT02469909: Comparison Between Immediate and Gradual Decannulation
Official title: Feasibility and Safety of Immediate Versus Gradual Decannulation: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheostomy
Keywords: Decannulation
tracheostomy
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
Collaborators: name: Soroka University Medical Center
First posted: 2015-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: re-insertion of the tracheostomy tube
timeFrame: 7 days
measure: mechanical ventilation
timeFrame: 7 days
Secondary outcomes:
measure: Death from any cause
timeFrame: 90 days
measure: Respiratory distress
timeFrame: up to 90 fays following decannulation
measure: Pneumonia
timeFrame: 90 days following decannulation
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan medical center
Study officials:
affiliation: Soroka hospital
name: Nili Segal, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1186/cc4887.
citation: Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33.
citation: Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41.
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.
citation: Lewarski JS. Long-term care of the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):534-7.
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. Epub 2012 Sep 18.
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. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.