Brain InjuryGODWEANNCT02235376
Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.
An observational study of Brain Injury, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain Injury
- What is being tested?
- weaning trial of mechanical ventilation
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: brain injured patients
Who may be able to join
- Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation
- Stable respiratory and hemodynamic conditions
- Ventilated patients for more than 48 hours
- Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg
- Therapeutic extubation
Who cannot join
- • Status epilepticus
- Cerebrospinal infection
- Patients under 15 years old
- Mechanical ventilation of < 48 h
- Spinal cord injury
- Withdrawal of life support
Trial locations and contacts
1 site in 1 country.
About this study
Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.
Read the detailed description
Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation.
Identification of clinical and biological criteria associated with failure of extubation.
Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis.
Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.
- Conditions
- Brain Injury
- Being tested
- weaning trial of mechanical ventilation
- Keywords
- Critical Care, Brain injured patients, Mechanical Ventilation, Weaning, Extubation, Prognostic score, Clinical examination
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weaning trial of mechanical ventilationOther
| Study group | Role | What they receive |
|---|---|---|
| critical care | Not described Receives: Other: weaning trial of mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay
Measured: at day 2
Secondary outcomes (9)
Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU
Measured: at ady 1
Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU
Measured: at day 1
Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU
Measured: at day 1
Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation
Measured: at day 1
cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay
Measured: at day 1
- Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation
Measured: at day 1
- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)
Measured: at day 2
Delay of extubation from intubation day (number of days)
Measured: at day 1
Glasgow Outcome Score (GOS)
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Russell CHABANNE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235376
- Sponsor's protocol ID
- CHU-0201
- Acronym
- GODWEAN
- Status last verified
- Oct 2015
- First submitted
- 28 Jul 2014
- Last updated
- 15 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.
- ClinicalTrials.gov ID
- NCT02235376
- Acronym / sponsor ID
- GODWEAN / CHU-0201
- Conditions
- Brain Injury
- Keywords
- Critical Care, Brain injured patients, Mechanical Ventilation, Weaning, Extubation, Prognostic score, Clinical examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Sep 2014 (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.
Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.
Detailed description
Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation.
Identification of clinical and biological criteria associated with failure of extubation.
Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis.
Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical care | – | Other: weaning trial of mechanical ventilation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- brain injured patients
Key inclusion criteria (5 listed)
- Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation
- Stable respiratory and hemodynamic conditions
- Ventilated patients for more than 48 hours
- Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg
- Therapeutic extubation
Key exclusion criteria (6 listed)
- • Status epilepticus
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 |
|---|---|---|
| weaning trial of mechanical ventilation | Other | critical care |
Primary outcome
Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
Time frame: at day 2
- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay
9 secondary outcomes
Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU
Time frame: at ady 1
Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU
Time frame: at day 1
Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU
Time frame: at day 1
Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation
Time frame: at day 1
cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay
Time frame: at day 1
- Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation
Time frame: at day 1
- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)
Time frame: at day 2
Delay of extubation from intubation day (number of days)
Time frame: at day 1
Glasgow Outcome Score (GOS)
Time frame: at 6 months
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 15 Oct 2015.
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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.
Russell CHABANNE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 6 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 15 Oct 2015. 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?
Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation (time frame: at day 2). 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 15 Oct 2015.