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

Primary Purpose

Tracheostomy, Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standardized 5-step weaning procedure
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tracheostomy focused on measuring Tracheostomy, Decannulation, Rehabilitation, Brain injury, Neurosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental procedure

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reasons of failure in weaning process
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
Mortality at 6 months
Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore
Communication subscore: 2 Functional Accurate 1 Non-Functional: Intentional 0 None
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

Full Information

First Posted
March 23, 2018
Last Updated
December 22, 2020
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03512054
Brief Title
Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
Acronym
DECATRAC
Official Title
Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheostomy, Brain Injuries
Keywords
Tracheostomy, Decannulation, Rehabilitation, Brain injury, Neurosurgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental procedure
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Standardized 5-step weaning procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of safe decannulation
Description
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.
Time Frame
Up to 3 month after weaning procedure start (Inclusion)
Secondary Outcome Measure Information:
Title
Reasons of failure in weaning process
Time Frame
Up to 3 month after weaning procedure start (Inclusion)
Title
Life threatening event occurrence during the weaning procedure
Description
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
Time Frame
Up to 3 month after weaning procedure start (Inclusion)
Title
Mortality at 6 months
Time Frame
6 month after weaning procedure start (Inclusion)
Title
Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore
Description
Communication subscore: 2 Functional Accurate 1 Non-Functional: Intentional 0 None
Time Frame
Up 6 month after weaning procedure start (Inclusion)
Title
Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score
Description
7 points scale: Level 1: Severe dysphagia: Unable to tolerate any Per Oral safely Level 7: Normal in all situations
Time Frame
Up 6 month after weaning procedure start (Inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric FRISON, MD
Organizational Affiliation
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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