Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit (DECAP-ICU)

March 9, 2023 updated by: Université de Sherbrooke
In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5H3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weaning from mechanical ventilation for at least 24 hours
  • Randomisation must be done in 24 hours of the mechanical ventilation weaning.

Exclusion Criteria:

  • Sabadell > 2
  • Contraindication of decannulation : Glasgow Coma Scale <6, severe dysphagia, non permeable respiratory tracks, neuromuscular disease (expect for the ICU weakness) and long term tracheostomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suction based protocol
Weaning protocol based on suctioning frequency. Once the weaning of mechanical ventilation, the patients in this arm will be on high-flow nasal canula. The canula will be remove if the decannulation conditions are met (if the patient require less than 2 aspirations in 8 hours for 24 consecutive hours)
Procedure: Suctioning based protocol
cf. arm The necessity of suctioning will be assed continuously by the nurses, respiratory therapist and the medical team. If the patient require 2 or less aspiration each 8 hours for 24 hours straight, an attempt of decanalution will be done.
Other: Usual care
Usual care will mainly base on the capping trial.
Procedure: Usual Care
Usual care in our center is tolerance to a capping trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to decannulation
Time Frame: Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months.
Time between the randomisation and the decannulation
Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to decannulation criteria
Time Frame: From date of randomisation to the date when the criteria of decannulation are met or to the date of death, whichever comes first, assessed up to 48 months.
Time between the randomisation and the criteria of decannulation
From date of randomisation to the date when the criteria of decannulation are met or to the date of death, whichever comes first, assessed up to 48 months.
Length of stay ICU
Time Frame: From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months.
Lenght of stay in the ICU.
From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months.
Length of stay hospital
Time Frame: From admission to the date when the patient is discharge of the hospital, through study completion, average of 6 to 12 months.
Length of stay in the hospital
From admission to the date when the patient is discharge of the hospital, through study completion, average of 6 to 12 months.
ICU readmission
Time Frame: Through study completion, average of 6 to 12 months.
ICU readmission
Through study completion, average of 6 to 12 months.
Decannulation failure
Time Frame: Through study completion, average of 6 to 12 months.
Necessity of reimplantation of a tracheostomy after the decannulation
Through study completion, average of 6 to 12 months.
Mechanical Ventilation weaning failure
Time Frame: Through study completion, average of 6 to 12 months.
Necessity of starting mechanical ventilation once the randomisation is started
Through study completion, average of 6 to 12 months.
Adverses effects
Time Frame: Through study completion, average of 6 to 12 months.
Pneumonia, sepsis, septic shock
Through study completion, average of 6 to 12 months.
Mortality
Time Frame: Through study completion, average of 6 to 12 months.
All cause mortality
Through study completion, average of 6 to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-4213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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