NCT06969443

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

May 5, 2025

Last Update Submit

September 23, 2025

Conditions

Keywords

ICURehabilitationMechanical ventilationObservationnal

Outcome Measures

Primary Outcomes (1)

  • 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)

    On Day 28 of study participation

Interventions

Rehabilitation 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Foreseeable invasive ventilation lasting more than 48 hours.
  • Included within the first five days of an intensive care stay.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SRLF

Paris, France

RECRUITING

Central Study Contacts

Guillaume FOSSAT, Physiotherapist Msc, PhD Student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations