Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison Between Immediate and Gradual Decannulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469909
Recruitment Status : Unknown
Verified February 2017 by Dr Oded Cohen, Kaplan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Soroka University Medical Center
Information provided by (Responsible Party):
Dr Oded Cohen, Kaplan Medical Center

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.

Condition or disease Intervention/treatment Phase
Tracheostomy Other: Overnight observation Other: Pre-discharge evaluation Other: outpatient clinic follow ups Procedure: immediate decannulation Procedure: Gradual tracheostomy tube decrease Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Immediate Versus Gradual Decannulation: a Randomised Control Trial
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. re-insertion of the tracheostomy tube [ Time Frame: 7 days ]
    number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation

  2. mechanical ventilation [ Time Frame: 7 days ]
    number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation


Secondary Outcome Measures :
  1. Death from any cause [ Time Frame: 90 days ]
    number of patients who died from any cause within 90 days of decannulation

  2. Respiratory distress [ Time Frame: up to 90 fays following decannulation ]
    number of patients who reported difficulty breathing suggestive of stridor or by examination or intervention within 90 days of decannulation

  3. Pneumonia [ Time Frame: 90 days following decannulation ]
    number of patients who had a diagnosis of pneumonia in the period of 90 days following decannulation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469909


Contacts
Layout table for location contacts
Contact: Oded Cohen, Dr +972-544682490 oded915@gmail.com
Contact: Yaara Haimovich +972-52-8580806 yaaraha@clalit.org.il

Locations
Layout table for location information
Israel
Kaplan medical center Recruiting
Rehovot, Israel
Contact: Oded Cohen, Dr    +972-54-468-2490    odedco@clalit.org.il   
Contact: Yaara Haimovich    +972-528580806    yaaraha@clalit.org.il   
Sponsors and Collaborators
Kaplan Medical Center
Soroka University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Nili Segal, Dr Soroka hospital
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Dr Oded Cohen, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02469909    
Other Study ID Numbers: ENTK 34-CTIL
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Keywords provided by Dr Oded Cohen, Kaplan Medical Center:
Decannulation
tracheostomy