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

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ClinicalTrials.gov Identifier: NCT03512054
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tracheostomy Brain Injuries Procedure: Standardized 5-step weaning procedure Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

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





Primary Outcome Measures :
  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 Outcome Measures :
  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



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

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

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): NCT03512054


Contacts
Contact: Thomas GALLICE 05 56 79 55 77 ext +33 thomas.gallice@chu-bordeaux.fr
Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 olivier.branchard@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Thomas GALLICE    05 56 79 55 77 ext +33    thomas.gallice@chu-bordeaux.fr   
Contact: Olivier BRANCHARD    05 57 82 06 97 ext +33    olivier.branchard@chu-bordeaux.fr   
Principal Investigator: Thomas GALLICE         
Sub-Investigator: Catherine AUBERT         
Sub-Investigator: Manuella BALAGUER         
Sub-Investigator: Emmanuelle CUGY, MD         
Sub-Investigator: Emmanuel CUNY, MD-PhD         
Sub-Investigator: Vincent JECKO, MD         
Sub-Investigator: Julie LAIMAY         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Eric FRISON, MD Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03512054     History of Changes
Other Study ID Numbers: CHUBX 2017/31
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Tracheostomy
Decannulation
Rehabilitation
Brain injury
Neurosurgery

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System