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

Not Applicable

Completed

• Conditions: Tracheostomy; Brain Injuries
• Interventions: Procedure: Standardized 5-step weaning procedure

• Registration Number: NCT03512054
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-30
• Study Start: 2018-06-20
• Primary Completion: 2019-12-24
• Status Verified: 2020-12
• Study Completion: 2020-12-18
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental procedure	Standardized 5-step weaning procedure	-

Primary Outcome Measures

Name	Time	Method
Number of safe decannulation	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

Name	Time	Method
Life threatening event occurrence during the weaning procedure	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
Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore	Up 6 month after weaning procedure start (Inclusion)	Communication subscore: * 2 Functional Accurate; * 1 Non-Functional: Intentional; * 0 None
Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score	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
Mortality at 6 months	6 month after weaning procedure start (Inclusion)
Reasons of failure in weaning process	Up to 3 month after weaning procedure start (Inclusion)

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France