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
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|
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|
|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
- 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.
- Reasons of failure in weaning process [ Time Frame: 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
- Mortality at 6 months [ Time Frame: 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) ]
- 2 Functional Accurate
- 1 Non-Functional: Intentional
- 0 None
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512054
|Contact: Thomas GALLICE||05 56 79 55 77 ext +email@example.com|
|Contact: Olivier BRANCHARD||05 57 82 06 97 ext +firstname.lastname@example.org|
|CHU de Bordeaux||Recruiting|
|Bordeaux, France, 33000|
|Contact: Thomas GALLICE 05 56 79 55 77 ext +33 email@example.com|
|Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 firstname.lastname@example.org|
|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|
|Study Chair:||Eric FRISON, MD||Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux|