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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03316-47 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of safe decannulation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons of failure in weaning process | Up to 3 month after weaning procedure start (Inclusion) | |
| Life threatening event occurrence during the weaning procedure | Life threatening event is defined by one of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
Malnutrition (defines by the age) :
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| Name | Affiliation | Role |
|---|---|---|
| Eric FRISON, MD | Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38062168 | Result | Gallice T, Cugy E, Germain C, Barthelemy C, Laimay J, Gaube J, Engelhardt M, Branchard O, Maloizel E, Frison E, Dehail P, Cuny E. A Pluridisciplinary Tracheostomy Weaning Protocol for Brain-Injured Patients, Outside of the Intensive Care Unit and Without Instrumental Assessment: Results of Pilot Study. Dysphagia. 2024 Aug;39(4):608-622. doi: 10.1007/s00455-023-10641-7. Epub 2023 Dec 7. |
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|
| Up to 3 month after weaning procedure start (Inclusion) |
| Mortality at 6 months | 6 month after weaning procedure start (Inclusion) |
| Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore | Communication subscore:
| Up 6 month after weaning procedure start (Inclusion) |
| Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score | 7 points scale:
| Up 6 month after weaning procedure start (Inclusion) |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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