Acute Brain InjuryReVENtSNCT07067671
Regional Ventilation Evaluation During Neuro-injury Weaning Study
An observational study of Acute Brain Injury and Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study evaluates changes in regional lung ventilation using thoracic electrical impedance tomography (EIT) during the weaning process from mechanical ventilation in ICU patients with acute brain injury. It aims to identify predictive EIT patterns related to extubation outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Mechanical Ventilation, Prolonged Weaning
- What is being tested?
- Internal Thoracic Impedance
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients hospitalized in intensive care for an acute brain injury under invasive mechanical ventilation for more than 48 hours.
Who may be able to join
- Age 18 or older
- Hospitalized in intensive care for an acute brain injury.
- Mechanical ventilation for more than 48 hours.
- Ventilator withdrawal planned in the next few days
- Social security coverage
Who cannot join
- Pregnancy
- Moribund patient / decision to stop treatment
- Patient under state medical aid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Lariboisière - APHP
Paris, France, 75010
Samuel G Gaugain, Doctor of medicine, +330149958518, samuel.gaugain@aphp.fr
About this study
Official title: Evaluation of Regional Ventilation in Neuro-injured Patients Undergoing Weaning From Mechanical Ventilation
This study evaluates changes in regional lung ventilation using thoracic electrical impedance tomography (EIT) during the weaning process from mechanical ventilation in ICU patients with acute brain injury. It aims to identify predictive EIT patterns related to extubation outcomes.
Read the detailed description
This is a prospective, single-center pilot study conducted in the intensive care unit. The study focuses on adult patients with acute brain injury requiring invasive mechanical ventilation for more than 48 hours. The aim is to assess regional alveolar ventilation using thoracic electrical impedance tomography (EIT) during different stages of ventilator weaning, including changes in ventilatory mode, spontaneous breathing trials, and, when feasible, around extubation or decannulation.
EIT provides dynamic, non-invasive real-time imaging of regional pulmonary ventilation. Data will be collected using a 16-electrode thoracic belt and analyzed retrospectively with dedicated software. The primary outcome measure is the Absolute Ventral-to-Dorsal Ventilation Difference, calculated from predefined regions of interest. Secondary outcomes include correlations with traditional ventilatory parameters (tidal volume, respiratory rate, oxygen saturation), end-expiratory impedance variation (ΔEELI), compliance changes, and extubation or decannulation failure defined by the need for reintubation within 7 days.
This study aims to improve understanding of regional ventilation patterns in brain-injured patients and assess the potential of EIT to predict weaning outcomes and guide personalized ventilatory strategies.
- Conditions
- Acute Brain Injury, Mechanical Ventilation, Prolonged Weaning, Traumatic Brain Injury, Hypoxic-Ischemic Brain Injury, Intracerebral Hemorrhage
- Being tested
- Internal Thoracic Impedance
- Keywords
- Electrical Impedance Tomography, Ventilator Weaning, Neurocritical Care, ICU Monitoring, Spontaneous Breathing Trial, Extubation Failure, Respiratory Mechanics, PulmoVista, EIT, Brain-Injured Patients
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Hypoxia-Ischemia, Brain, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Thoracic ImpedanceOther
Internal Thoracic Impedance is a non-invasive an imaging technique which use low alternative current through electrodes placed on a belt positioned at the level of the patient's rib cage. Images are constructed according to conductivity measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute ventral-to-dorsal ventilation difference
The Absolute V-D Difference will be calculated as the average of the ventilation in the ventral regions (ROI1 and ROI2) minus the average of the ventilation in the dorsal regions (ROI3 and ROI4) during mechanical ventilation weaning. This outcome will provide insights into regional pulmonary ventilation distribution and its correlation with extubation outcomes.
This difference is calculated as follows: (ROI_Value1 + ROI_Value2)/2 - (ROI_Value3 + ROI_Value4)/2 expressed as a percentage.
Measured: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after.
Secondary outcomes (5)
Correlation between Absolute V-D Difference and Conventional Ventilatory Parameters
This outcome will evaluate how the Absolute V-D Difference correlates with other monitoring parameters, such as tidal volume, respiratory rate, SpO₂, and end-tidal CO₂ (EtCO₂), throughout the weaning process.
Measured: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after
End-Expiratory Lung Impedance (ΔEELI)
The monitoring of ΔEELI will be continuous throughout the spontaneous breathing trial, which lasts 30 minutes. Monitoring will begin at a stable baseline 5 minutes prior to the start of the trial and will continue until 5 minutes after its completion.
Three specific time points will be collected and analyzed:
- EELI before the trial (baseline, 5 minutes prior),
- EELI at the end of the trial (30 minutes),
- EELI 5 minutes after resumption of mechanical ventilation
Measured: From 5 minutes before to 5 minutes after the 30-minute spontaneous breathing trial (i.e., total duration of 40 minutes)
Correlation between ΔEELI and Extubation/Decannulation Failure
This secondary outcome assesses the relationship between changes in end-expiratory impedance (ΔEELI) and extubation or decannulation failure, defined as reintubation or need for reventilation within 7 days.
Measured: 7 days post-extubation or post-deventilation.
Pulmonary Compliance Variation during Ventilator Changes and Spontaneous Breathing Trials
This measure will track the changes in regional pulmonary compliance in response to adjustments in ventilator parameters (e.g., PEEP, tidal volume) and spontaneous breathing trials.
Measured: From the start of ventilator mode change or spontaneous breathing trial until 30 minutes after.
Absolute V-D Difference and Extubation Failure
This outcome will examine the correlation between the Absolute V-D Difference and extubation failure, defined as reintubation or the need for reventilation within 7 days post-extubation or post-deventilation.
Measured: 7 days post-extubation or post-deventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Gaugain, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067671
- Sponsor's protocol ID
- APHP250700
- Other IDs
- 2025-A01069-40
- Acronym
- ReVENtS
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Ventilation in Neuro-injured Patients Undergoing Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07067671
- Acronym / sponsor ID
- ReVENtS / APHP250700
- Conditions
- Acute Brain Injury, Mechanical Ventilation, Prolonged Weaning, Traumatic Brain Injury, Hypoxic-Ischemic Brain Injury, Intracerebral Hemorrhage
- Keywords
- Electrical Impedance Tomography, Ventilator Weaning, Neurocritical Care, ICU Monitoring, Spontaneous Breathing Trial, Extubation Failure, Respiratory Mechanics, PulmoVista
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Jul 2025 (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.
This study evaluates changes in regional lung ventilation using thoracic electrical impedance tomography (EIT) during the weaning process from mechanical ventilation in ICU patients with acute brain injury. It aims to identify predictive EIT patterns related to extubation outcomes.
Detailed description
This is a prospective, single-center pilot study conducted in the intensive care unit. The study focuses on adult patients with acute brain injury requiring invasive mechanical ventilation for more than 48 hours. The aim is to assess regional alveolar ventilation using thoracic electrical impedance tomography (EIT) during different stages of ventilator weaning, including changes in ventilatory mode, spontaneous breathing trials, and, when feasible, around extubation or decannulation.
EIT provides dynamic, non-invasive real-time imaging of regional pulmonary ventilation. Data will be collected using a 16-electrode thoracic belt and analyzed retrospectively with dedicated software. The primary outcome measure is the Absolute Ventral-to-Dorsal Ventilation Difference, calculated from predefined regions of interest. Secondary outcomes include correlations with traditional ventilatory parameters (tidal volume, respiratory rate, oxygen saturation), end-expiratory impedance variation (ΔEELI), compliance changes, and extubation or decannulation failure defined by the need for reintubation within 7 days.
This study aims to improve understanding of regional ventilation patterns in brain-injured patients and assess the potential of EIT to predict weaning outcomes and guide personalized ventilatory strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in intensive care for an acute brain injury under invasive mechanical ventilation for more than 48 hours.
Key inclusion criteria (5 listed)
- Age 18 or older
- Hospitalized in intensive care for an acute brain injury.
- Mechanical ventilation for more than 48 hours.
- Ventilator withdrawal planned in the next few days
- Social security coverage
Key exclusion criteria (3 listed)
- Pregnancy
- Moribund patient / decision to stop treatment
- Patient under state medical aid
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 |
|---|---|---|
| Internal Thoracic ImpedanceInternal Thoracic Impedance is a non-invasive an imaging technique which use low alternative current through electrodes placed on a belt positioned at the level of the patient's rib cage. Images are constructed according to conductivity measured. | Other | – |
Primary outcome
Absolute ventral-to-dorsal ventilation difference
Time frame: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after.
The Absolute V-D Difference will be calculated as the average of the ventilation in the ventral regions (ROI1 and ROI2) minus the average of the ventilation in the dorsal regions (ROI3 and ROI4) during mechanical ventilation weaning. This outcome will provide insights into regional pulmonary ventilation distribution and its correlation with extubation outcomes. This difference is calculated as follows: (ROI_Value1 + ROI_Value2)/2 - (ROI_Value3 + ROI_Value4)/2 expressed as a percentage.
5 secondary outcomes
Correlation between Absolute V-D Difference and Conventional Ventilatory Parameters
Time frame: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after
End-Expiratory Lung Impedance (ΔEELI)
Time frame: From 5 minutes before to 5 minutes after the 30-minute spontaneous breathing trial (i.e., total duration of 40 minutes)
Correlation between ΔEELI and Extubation/Decannulation Failure
Time frame: 7 days post-extubation or post-deventilation.
Pulmonary Compliance Variation during Ventilator Changes and Spontaneous Breathing Trials
Time frame: From the start of ventilator mode change or spontaneous breathing trial until 30 minutes after.
Absolute V-D Difference and Extubation Failure
Time frame: 7 days post-extubation or post-deventilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- 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.
Samuel Gaugain, MD principal investigator
APHP
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 Acute Brain Injury and Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris 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 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: opening soon, as of the sponsor's last update on 19 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Gaugain, MD (+330149958518, samuel.gaugain@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute ventral-to-dorsal ventilation difference (time frame: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after.). 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 19 Feb 2026.