Severe Brain InjuryNCT02426242
Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.
An observational study of Severe Brain Injury, run by Nantes University Hospital at 3 sites in France.
Trial summary
Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Severe Brain Injury
- What is being tested?
- Collection of medical data from ICU patients
- How many people
- 450 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2013to Jul 2014
- Phase
- Observational
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in ICU for severe brain injury
Who may be able to join
- Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission
Who cannot join
- Pregnant women
- Patient consent withdrawal
Trial locations and contacts
3 sites in 1 country.
France3 sites
Angers University Hospital
Angers, 49000
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes, 35000
About this study
Official title: Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients
Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.
To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients
- Conditions
- Severe Brain Injury
- Being tested
- Collection of medical data from ICU patients
- Keywords
- brain-injury, extubation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of medical data from ICU patientsOther
A code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay.
| Study group | Role | What they receive |
|---|---|---|
| ICU PATIENTS | Patients with brain-injury Receives: Other: Collection of medical data from ICU patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Extubation failure is regarded as the need of intubation in the 48 hours following extubation Establish clinial signs before extubation that can predict extubation failure Realization of a systematic clinical examination by the attending physician before performing extubation in severe brain-injured patients
Measured: In the 48 hours following extubation
Secondary outcomes (1)
Impact of extubation failure
Impact of extubation failure on
- Duration of mechanical ventilation
- Length of ICU stay
- Mortality Describing reasons
Measured: Median 14 days after Intensive Care Unit (ICU) admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Brain InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël Cinotti, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426242
- Sponsor's protocol ID
- RC13_0354
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients
- ClinicalTrials.gov ID
- NCT02426242
- Acronym / sponsor ID
- RC13_0354
- Conditions
- Severe Brain Injury
- Keywords
- brain-injury, extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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.
Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.
To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU PATIENTS | – | Other: Collection of medical data from ICU patientsPatients with brain-injury |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in ICU for severe brain injury
Key inclusion criteria (1 listed)
- Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission
Key exclusion criteria (2 listed)
- Pregnant women
- Patient consent withdrawal
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 |
|---|---|---|
| Collection of medical data from ICU patientsA code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay. | Other | ICU PATIENTS |
Primary outcome
Extubation failure
Time frame: In the 48 hours following extubation
Extubation failure is regarded as the need of intubation in the 48 hours following extubation Establish clinial signs before extubation that can predict extubation failure Realization of a systematic clinical examination by the attending physician before performing extubation in severe brain-injured patients
1 secondary outcome
Impact of extubation failure
Time frame: Median 14 days after Intensive Care Unit (ICU) admission
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 13 Sep 2016.
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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.
Raphaël Cinotti, MD principal investigator
Nantes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Brain Injury, run by Nantes University Hospital at 3 sites 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 1 inclusion and 2 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Extubation failure (time frame: In the 48 hours following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2016.