Clinical trial NCT03512054: Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
Official title: Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy
Brain Injuries
Keywords: Tracheostomy
Decannulation
Rehabilitation
Brain injury
Neurosurgery
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of safe decannulation
timeFrame: Up to 3 month after weaning procedure start (Inclusion)
Secondary outcomes:
measure: Reasons of failure in weaning process
timeFrame: Up to 3 month after weaning procedure start (Inclusion)
measure: Life threatening event occurrence during the weaning procedure
timeFrame: Up to 3 month after weaning procedure start (Inclusion)
measure: Mortality at 6 months
timeFrame: 6 month after weaning procedure start (Inclusion)
measure: Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore
timeFrame: Up 6 month after weaning procedure start (Inclusion)
measure: Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score
timeFrame: Up 6 month after weaning procedure start (Inclusion)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
name: Eric FRISON, MD
role: STUDY_CHAIR
References: