Brain-injuryBI-VILINCT01885507
Mechanical Ventilation in Brain-injured Patients
An observational study of Brain-injury and Stroke, run by Nantes University Hospital at 22 sites in France.
Trial summary
Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain-injury, Stroke, Subarachnoid Haemorrhage
- What is being tested?
- Pass recommendations on ventilation factors and extubation
- How many people
- 560 participants
- Where
- 22 sitesFrance
- Study dates
- Jul 2013to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Structural coma.
Who may be able to join
- Adult patients (traumatic brain-injured, subarachnoid hemorrhage, stroke or other)
- Brain injury (Glasgow Coma Scale ≤ 12 associated with at least one anomaly related to an acute process on head tomographic tomodensitometry
- mechanical ventilation for more than 24 hours
Who cannot join
- early decision to withdraw care (taken in the first 24 hours in ICU),
- death in the first 24 hours
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Angers University Hospital
Angers
Beaujon Hospital
Beaujon
Brest University Hospital
Brest
Caen University Hospital
Caen
Clermont-Ferrand University Hospital
Clermont-Ferrand
Henri Mondor University Hospital
Créteil
Grenoble University Hospital
Grenoble
Bicêtre University Hospital
Le Kremlin-Bicêtre
Marseille University Hospital
Marseille
Montpellier University Hospital
Montpellier
Nantes University Hospital
Nantes
Nice University Hospital
Nice
Nimes University Hospital
Nîmes
Georges Pompidou European Hospital
Paris
Poitiers University Hospital
Poitiers
Rennes University Hospital
Rennes
Rouen University Hospital
Rouen
Nantes University Hospital
Saint-Herblain
Toulouse University Hospital - Purpan
Toulouse
Toulouse University Hospital - Rangueil
Toulouse
Tours Univeristy Hospital - Neurosurgery ICU
Tours
Tours University Hospital - Neurotrauma ICU
Tours
About this study
Official title: Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project
Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.
We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.
Read the detailed description
A before/after study design will be used. The before period (control phase) will consisted of all consecutive patients with severe brain-injury who were admitted to the participating ICUs.
During the interphase, all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the 2 point bundle: protective ventilation and systematic approach to extubation (according to recommendation for the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) and extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cought).
The after period consisted of all consecutive severe brain-injured patients admitted to the participating ICUs after the formal training.
- Being tested
- Pass recommendations on ventilation factors and extubation
- Medical subject headings
- Brain Injuries, Stroke, Subarachnoid Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pass recommendations on ventilation factors and extubationOther
- the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
- extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough
| Study group | Role | What they receive |
|---|---|---|
| Control phase (before) | Process of care and outcomes before the educational program | |
| Training phase (after) | Process of care and outcomes after the educational program which recommends:
* the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
* extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough Receives: Other: Pass recommendations on ventilation factors and extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilatory free days
The number of ventilator-free days was defined as the number of days from day 1 to day 90 on which a patient breaths spontaneously and is alive
Measured: Day-90
Secondary outcomes (11)
Mortality
Measured: day-90
In-ICU mortality
Measured: 90 days
Duration of mechanical ventilation
Measured: 90 days
ICU free days at day 90
The number of ICU free days was defined as the number of days from day 1 to on which a patient is alive and not hospitalized in ICU
Measured: day 90
Acute respiratory distress syndrome / acute lung injury
Measured: day-90
Hospital acquired pneumonia
Measured: day-90
Blood gaz
PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon)
Measured: day-5
Intracranial pressure
Measured: day-5
Glasgow outcome scale
Measured: day-90
Extubation failure
Measured: day-90
Ventilatory setting
Tidal volume and Positive end expiratory pressure
Measured: day-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
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 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Asehnoune, MD, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885507
- Sponsor's protocol ID
- RC13_0127
- Acronym
- BI-VILI
- Status last verified
- Jan 2015
- First submitted
- 18 Jun 2013
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Asehnoune K, Mrozek S, Perrigault PF, Seguin P, Dahyot-Fizelier C, Lasocki S, Pujol A, Martin M, Chabanne R, Muller L, Hanouz JL, Hammad E, Rozec B, Kerforne T, Ichai C, Cinotti R, Geeraerts T, Elaroussi D, Pelosi P, Jaber S, Dalichampt M, Feuillet F, Sebille V, Roquilly A; BI-VILI study group. A multi-faceted strategy to reduce ventilation-associated mortality in brain-injured patients. The BI-VILI project: a nationwide quality improvement project. Intensive Care Med. 2017 Jul;43(7):957-970. doi: 10.1007/s00134-017-4764-6. Epub 2017 Mar 18.
PubMed 28315940
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project
- ClinicalTrials.gov ID
- NCT01885507
- Acronym / sponsor ID
- BI-VILI / RC13_0127
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jun 2013 (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.
Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.
We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.
Detailed description
A before/after study design will be used. The before period (control phase) will consisted of all consecutive patients with severe brain-injury who were admitted to the participating ICUs.
During the interphase, all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the 2 point bundle: protective ventilation and systematic approach to extubation (according to recommendation for the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) and extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cought).
The after period consisted of all consecutive severe brain-injured patients admitted to the participating ICUs after the formal training.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control phase (before) | – | –Process of care and outcomes before the educational program |
| Training phase (after) | – | Other: Pass recommendations on ventilation factors and extubationProcess of care and outcomes after the educational program which recommends: * the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) * extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Structural coma.
Key inclusion criteria (3 listed)
- Adult patients (traumatic brain-injured, subarachnoid hemorrhage, stroke or other)
- Brain injury (Glasgow Coma Scale ≤ 12 associated with at least one anomaly related to an acute process on head tomographic tomodensitometry
- mechanical ventilation for more than 24 hours
Key exclusion criteria (2 listed)
- early decision to withdraw care (taken in the first 24 hours in ICU),
- death in the first 24 hours
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 |
|---|---|---|
| Pass recommendations on ventilation factors and extubation* the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) * extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough | Other | Training phase (after) |
Primary outcome
Mechanical ventilatory free days
Time frame: Day-90
The number of ventilator-free days was defined as the number of days from day 1 to day 90 on which a patient breaths spontaneously and is alive
11 secondary outcomes
Mortality
Time frame: day-90
In-ICU mortality
Time frame: 90 days
Duration of mechanical ventilation
Time frame: 90 days
ICU free days at day 90
Time frame: day 90
Acute respiratory distress syndrome / acute lung injury
Time frame: day-90
Hospital acquired pneumonia
Time frame: day-90
Blood gaz
Time frame: day-5
Intracranial pressure
Time frame: day-5
Glasgow outcome scale
Time frame: day-90
Extubation failure
Time frame: day-90
Ventilatory setting
Time frame: day-5
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 23 Feb 2015.
- Derived from this study: PubMed 28315940Asehnoune K, Mrozek S, Perrigault PF, Seguin P, Dahyot-Fizelier C, Lasocki S, Pujol A, Martin M, Chabanne R, Muller L, Hanouz JL, Hammad E, Rozec B, Kerforne T, Ichai C, Cinotti R, Geeraerts T, Elaroussi D, Pelosi P, Jaber S, Dalichampt M, Feuillet F, Sebille V, Roquilly A; BI-VILI study group. A multi-faceted strategy to reduce ventilation-associated mortality in brain-injured patients. The BI-VILI project: a nationwide quality improvement project. Intensive Care Med. 2017 Jul;43(7):957-970. doi: 10.1007/s00134-017-4764-6. Epub 2017 Mar 18.
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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.
Karim Asehnoune, MD, PhD principal investigator
Nantes University Hospital
22 sites 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 and Stroke, run by Nantes University Hospital at 22 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 3 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Mechanical ventilatory free days (time frame: Day-90). 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 NCT01885507, 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 23 Feb 2015.