TracheostomyDECATRACNCT03512054
Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
A study testing Standardized 5-step weaning procedure in people with Tracheostomy and Brain Injuries, run by University Hospital, Bordeaux at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Brain Injuries
- What is being tested?
- Standardized 5-step weaning procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2018to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Tracheostomy, Brain Injuries
- Being tested
- Standardized 5-step weaning procedure
- Keywords
- Tracheostomy, Decannulation, Rehabilitation, Brain injury, Neurosurgery
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized 5-step weaning procedureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental procedure | Experimental | Not described Receives: Procedure: Standardized 5-step weaning procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 month after weaning procedure start (Inclusion)
Secondary outcomes (5)
Reasons of failure in weaning process
Measured: Up to 3 month after weaning procedure start (Inclusion)
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
Measured: Up to 3 month after weaning procedure start (Inclusion)
Mortality at 6 months
Measured: 6 month after weaning procedure start (Inclusion)
Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore
Communication subscore:
- 2 Functional Accurate
- 1 Non-Functional: Intentional
- 0 None
Measured: Up 6 month after weaning procedure start (Inclusion)
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
Measured: Up 6 month after weaning procedure start (Inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start20 Jun 2018
- Primary completion24 Dec 2019
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric FRISON, MD, Study chair, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512054
- Sponsor's protocol ID
- CHUBX 2017/31
- Other IDs
- 2017-A03316-47
- Acronym
- DECATRAC
- Status last verified
- Dec 2020
- First submitted
- 23 Mar 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallice T, Cugy E, Germain C, Barthelemy C, Laimay J, Gaube J, Engelhardt M, Branchard O, Maloizel E, Frison E, Dehail P, Cuny E. A Pluridisciplinary Tracheostomy Weaning Protocol for Brain-Injured Patients, Outside of the Intensive Care Unit and Without Instrumental Assessment: Results of Pilot Study. Dysphagia. 2024 Aug;39(4):608-622. doi: 10.1007/s00455-023-10641-7. Epub 2023 Dec 7.
PubMed 38062168
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
- ClinicalTrials.gov ID
- NCT03512054
- Acronym / sponsor ID
- DECATRAC / CHUBX 2017/31
- Conditions
- Tracheostomy, Brain Injuries
- Keywords
- Tracheostomy, Decannulation, Rehabilitation, Brain injury, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental procedure | Experimental | Procedure: Standardized 5-step weaning procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age at least 18 years old
- brain-injury disease
- tracheotomy act while in neurosurgery or reanimation stay
- no artificial ventilation
- medical cover
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized 5-step weaning procedureWeaning 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 | Procedure or surgery | Experimental procedure |
Primary outcome
Number of safe decannulation
Time frame: 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.
5 secondary outcomes
Reasons of failure in weaning process
Time frame: Up to 3 month after weaning procedure start (Inclusion)
Life threatening event occurrence during the weaning procedure
Time frame: Up to 3 month after weaning procedure start (Inclusion)
Mortality at 6 months
Time frame: 6 month after weaning procedure start (Inclusion)
Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore
Time frame: Up 6 month after weaning procedure start (Inclusion)
Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score
Time frame: Up 6 month after weaning procedure start (Inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 38062168Gallice T, Cugy E, Germain C, Barthelemy C, Laimay J, Gaube J, Engelhardt M, Branchard O, Maloizel E, Frison E, Dehail P, Cuny E. A Pluridisciplinary Tracheostomy Weaning Protocol for Brain-Injured Patients, Outside of the Intensive Care Unit and Without Instrumental Assessment: Results of Pilot Study. Dysphagia. 2024 Aug;39(4):608-622. doi: 10.1007/s00455-023-10641-7. Epub 2023 Dec 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric FRISON, MD study chair
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized 5-step weaning procedure in people with Tracheostomy and Brain Injuries, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of safe decannulation (time frame: Up to 3 month after weaning procedure start (Inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.