Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients (DECATRAC)

May 11, 2026 updated by: University Hospital, Bordeaux

Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury).

However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily.

This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brain injury patients with alertness disorders, wake-up delay and / or swallowing disorders, frequently have a tracheotomy. This tracheotomy is often a problem when it comes to find a bed in a secondary care unit, which is better adapted to the patient rehabilitation. Unfortunately, there is little room to accept this type of patient. It is therefore appropriate to do the weaning during the neurosurgery unit stay.

Bibliographical studies indicate few recommendations as to weaning outside intensive care units. In the neurosurgery units at the University Hospital of Bordeaux, during 3 years (2014-2016), investigators have practiced 29 decannulations without recannulation, over 37 brain injury patients, with a multi-professional team (neurosurgeon, physiotherapist, nurse, caregiver…) to produce a weaning process.

From where investigators hypothesis: using a multi-professional weaning process, checking the patient's stability during the different weaning steps, can lead to decide to decannulate or not without any risk.

Study Type

Interventional

Enrollment (Actual)

30

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

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age at least 18 years old
  • brain-injury disease
  • tracheotomy act while in neurosurgery or reanimation stay
  • no artificial ventilation
  • medical cover
  • free, informed and express consent by the patient or his legal representative (no later than the day after the inclusion and before all exam necessary for the research)

Exclusion Criteria:

Malnutrition (defines by the age) :

  • age < 70 years old: body mass index (B.D.I.) <16 kg/m² or albuminemia <20 g/L
  • age > 70 years old: body mass index (B.D.I.) <18 kg/m² or albuminemia <30 g/L

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental procedure
Procedure: Standardized 5-step weaning procedure

Weaning process in 5 steps (0-4), by a multi-professional team (neurosurgeon, physiotherapist, nurse, caregiver…) Stability criteria are defined for each person, after validation pass the next step. Stability criteria degradation return to the previous step. Weaning process can take back after stability criteria renormalization.

Step 0: cuff deflate. Step 1: occlusion test. Steps 0 and 1 can assess the freedom and protect capacity airway. In failure process, we can propose a nasofibroscopy.

Step 2: Phonatory Valve. Respiratory rehabilitation/ swallowing, limiting breathing effort. The valve ought to stay 12 hours before going to the step 3.

Step 3: Plug. Finish the Respiratory rehabilitation/ swallowing. The plug ought to stay 24hours minimum before going to the step 4.

Step 4: Decannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of safe decannulation
Time Frame: Up to 3 month after weaning procedure start (Inclusion)
The main objective is to determine the effectiveness of the standardized 5-step weaning procedure for selecting patients to be decannulated without failure. This is measured by the proportion of safe decannulation for all decannulated tracheotomised patients included in the study. The failure of decannulation is defined by a recannulation within 96h.
Up to 3 month after weaning procedure start (Inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons of failure in weaning process
Time Frame: Up to 3 month after weaning procedure start (Inclusion)
Up to 3 month after weaning procedure start (Inclusion)
Life threatening event occurrence during the weaning procedure
Time Frame: Up to 3 month after weaning procedure start (Inclusion)

Life threatening event is defined by one of the following:

  • cardiorespiratory failure,
  • septic shock,
  • cardiorespiratory arrest,
  • acute respiratory failure,
  • acute neurological condition or severe electrolyte disturbances
Up to 3 month after weaning procedure start (Inclusion)
Mortality at 6 months
Time Frame: 6 month after weaning procedure start (Inclusion)
6 month after weaning procedure start (Inclusion)
Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore
Time Frame: Up 6 month after weaning procedure start (Inclusion)

Communication subscore:

  • 2 Functional Accurate
  • 1 Non-Functional: Intentional
  • 0 None
Up 6 month after weaning procedure start (Inclusion)
Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score
Time Frame: Up 6 month after weaning procedure start (Inclusion)

7 points scale:

  • Level 1: Severe dysphagia: Unable to tolerate any Per Oral safely
  • Level 7: Normal in all situations
Up 6 month after weaning procedure start (Inclusion)

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Eric FRISON, MD, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

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 (Actual)

June 20, 2018

Primary Completion (Actual)

December 24, 2019

Study Completion (Actual)

December 18, 2020

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2017/31
  • 2017-A03316-47 (Other Identifier: ANSM)

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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