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Completed

NCT Number: NCT03512054

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized 5-step weaning procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Reasons of failure in weaning process

    Time frame: Up to 3 month after weaning procedure start (Inclusion)

  2. 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
  3. Mortality at 6 months

    Time frame: 6 month after weaning procedure start (Inclusion)

  4. 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
  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: DECATRAC

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 30, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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