Invasive Mechanical VentilationREHALITENCT06969443
Evaluation of Rehabilitation Practices in the Intensive Care Unit
An observational study of Invasive Mechanical Ventilation and Rehabilitation Exercise of ICU Patients, run by French Society for Intensive Care at 1 site in France.
Trial summary
This observational study aims to describe the number of rehabilitation procedures performed per patient during their stay in French-speaking adult intensive care units undergoing invasive mechanical ventilation (average rehabilitation ratio). The study aims to determine the actual rehabilitation ratio, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mechanical Ventilation, Rehabilitation Exercise of ICU Patients
- What is being tested?
- Rehabilitation Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2025to Dec 2026
- 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 undergoing mechanical ventilation (MV) via an endotracheal tube for less than five days, in French-speaking intensive care units in three countries (France, Belgium and Switzerland), in whom MV is scheduled to last more than 48 hours.
Who may be able to join
- Foreseeable invasive ventilation lasting more than 48 hours.
- Included within the first five days of an intensive care stay.
Who cannot join
- Participation in an interventional study on early rehabilitation in the ICU
- Moribund patient
- Pregnant or breastfeeding woman
- A person deprived of liberty by court order
- Not being affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Rehabilitation Practices in Patients Undergoing Invasive Mechanical Ventilation in French-speaking Critical Care Units
This observational study aims to describe the number of rehabilitation procedures performed per patient during their stay in French-speaking adult intensive care units undergoing invasive mechanical ventilation (average rehabilitation ratio). The study aims to determine the actual rehabilitation ratio, i.e. the number of rehabilitation procedures divided by the number of critical care hospital days (censored at day 28 from the start of invasive mechanical ventilation), provided to patients undergoing invasive mechanical ventilation. The rehabilitation procedure will remain the same, and ICU teams will only record the number of procedures performed per day.
- Being tested
- Rehabilitation Procedure
- Keywords
- ICU, Rehabilitation, Mechanical ventilation, Observationnal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation ProcedureProcedure or surgery
Rehabilitation procedure list :
- Passive limb mobilization
- Active (or active-assisted) limb mobilization
- Passive transfer to chair
- Active transfer to chair
- Sitting on edge of bed
- Standing table (or similar)
- Standing on legs
- Walking
- Cyclo-ergometer (bed or chair)
- Electrostimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitation Ratio
Number of rehabilitation procedures per day divided by the number of ICU days (censored at D28 from the start of invasive mechanical ventilation)
Measured: On Day 28 of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start17 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969443
- Sponsor's protocol ID
- SRLF-012025
- Other IDs
- 2025-A00025-44
- Acronym
- REHALITE
- Status last verified
- Sep 2025
- First submitted
- 5 May 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rehabilitation Practices in Patients Undergoing Invasive Mechanical Ventilation in French-speaking Critical Care Units
- ClinicalTrials.gov ID
- NCT06969443
- Acronym / sponsor ID
- REHALITE / SRLF-012025
- Keywords
- ICU, Rehabilitation, Mechanical ventilation, Observationnal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 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 observational study aims to describe the number of rehabilitation procedures performed per patient during their stay in French-speaking adult intensive care units undergoing invasive mechanical ventilation (average rehabilitation ratio). The study aims to determine the actual rehabilitation ratio, i.e. the number of rehabilitation procedures divided by the number of critical care hospital days (censored at day 28 from the start of invasive mechanical ventilation), provided to patients undergoing invasive mechanical ventilation. The rehabilitation procedure will remain the same, and ICU teams will only record the number of procedures performed per day.
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 undergoing mechanical ventilation (MV) via an endotracheal tube for less than five days, in French-speaking intensive care units in three countries (France, Belgium and Switzerland), in whom MV is scheduled to last more than 48 hours.
Key inclusion criteria (2 listed)
- Foreseeable invasive ventilation lasting more than 48 hours.
- Included within the first five days of an intensive care stay.
Key exclusion criteria (5 listed)
- Participation in an interventional study on early rehabilitation in the ICU
- Moribund patient
- Pregnant or breastfeeding woman
- A person deprived of liberty by court order
- Not being affiliated to a social security scheme
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 |
|---|---|---|
| Rehabilitation ProcedureRehabilitation procedure list : 1. Passive limb mobilization 2. Active (or active-assisted) limb mobilization 3. Passive transfer to chair 4. Active transfer to chair 5. Sitting on edge of bed 6. Standing table (or similar) 7. Standing on legs 8. Walking 9. Cyclo-ergometer (bed or chair) 10. Electrostimulation | Procedure or surgery | – |
Primary outcome
Rehabilitation Ratio
Time frame: On Day 28 of study participation
Number of rehabilitation procedures per day divided by the number of ICU days (censored at D28 from the start of invasive mechanical ventilation)
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 24 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Invasive Mechanical Ventilation and Rehabilitation Exercise of ICU Patients, run by French Society for Intensive Care 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. 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 Guillaume FOSSAT, Physiotherapist Msc, PhD Student (+331 45 86 74 00, secretariat@srlf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation Ratio (time frame: On Day 28 of study participation). 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 24 Sep 2025.