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

Brain Injuries Clinical Trial

— DECATRAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512054
• Other study ID #: CHUBX 2017/31
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: December 18, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 18, 2020
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Tracheostomy
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Reasons of failure in weaning process		Up to 3 month after weaning procedure start (Inclusion)
Secondary	Life threatening event occurrence during the weaning procedure	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	Up to 3 month after weaning procedure start (Inclusion)
Secondary	Mortality at 6 months		6 month after weaning procedure start (Inclusion)
Secondary	Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore	Communication subscore: 2 Functional Accurate; 1 Non-Functional: Intentional; 0 None	Up 6 month after weaning procedure start (Inclusion)
Secondary	Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score	7 points scale: Level 1: Severe dysphagia: Unable to tolerate any Per Oral safely; Level 7: Normal in all situations	Up 6 month after weaning procedure start (Inclusion)