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

University Hospital of Bordeaux

Status: Completed

Conditions: Brain Injuries; Tracheostomy

Treatments: Procedure: Standardized 5-step weaning procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03512054

CHUBX 2017/31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Experimental procedure

Experimental group

Treatment:

Procedure: Standardized 5-step weaning procedure