NCT02469909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3 years

First QC Date

June 4, 2015

Last Update Submit

February 28, 2017

Conditions

Tracheostomy

Keywords

Decannulationtracheostomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Death from any cause

    90 days

  • Respiratory distress

    up to 90 fays following decannulation

  • Pneumonia

    90 days following decannulation

Study Arms (2)

immediate decannulation

OTHER

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 observationOther: Pre-discharge evaluationOther: outpatient clinic follow upsProcedure: immediate decannulation

Gradual tracheostomy tube decrease

OTHER

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 upsProcedure: Gradual tracheostomy tube decrease

Interventions

Overnight observationOTHER

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.

immediate decannulation
Pre-discharge evaluationOTHER

After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.

immediate decannulation
outpatient clinic follow upsOTHER

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

Gradual tracheostomy tube decreaseimmediate decannulation
immediate decannulationPROCEDURE

the tracheostomy tube is removed at once

immediate decannulation
Gradual tracheostomy tube decreasePROCEDURE

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

Gradual tracheostomy tube decrease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent tracheostomy with the following conditions:
  • Tracheostomy tract is established more than 7 days
  • Normal vital signs: heart rate 50-100, 90\<systolic BP \<180, respiratory rate \<20. Saturation \>90% in room air
  • Effective cough
  • Normal swallows \\ feeding possibility
  • \# 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.
  • Ability of the patient to breath with a capped cannula.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan medical center

Rehovot, Rehovot, Israel

RECRUITING

Related Publications (8)

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

    PMID: 15807905BACKGROUND

  • 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.

    PMID: 16606435BACKGROUND

  • Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33.

    PMID: 15807916BACKGROUND

  • Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41.

    PMID: 15807918BACKGROUND

  • 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.

    PMID: 10155745BACKGROUND

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

    PMID: 15807917BACKGROUND

  • 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.

    PMID: 22990518RESULT

  • 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.

    PMID: 17588767RESULT

Study Officials

  • Nili Segal, Dr

    Soroka hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oded Cohen, Dr

CONTACT

+972-544682490oded915@gmail.com

Yaara Haimovich

CONTACT

+972-52-8580806yaaraha@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Oded Cohen

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

January 1, 2019

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

IL(1)