Sitting ventilated ICU patients in an armchair to improve recovery.

Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients: a Prospective Randomized Controlled Trial

This test will try sitting adults on mechanical ventilation in an armchair to see if it helps their breathing, strength, and recovery after an ICU stay.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Régional d'Orléans (other)
• Locations: 11 sites (Orléans, Centre-Val de Loire and 10 other locations)
• Trial ID: NCT06973746 on ClinicalTrials.gov

What this trial studies

Researchers will compare early armchair positioning with a conservative in-bed positioning strategy in adult ICU patients who have been invasively ventilated for more than 24 hours. Eligible patients are medically stable (RASS > -3), expected to remain in the ICU at least 48 hours, and have not previously been placed in a chair during the current stay. The intervention moves patients out of the resuscitation bed into an armchair as part of early mobilization, and outcomes focus on functional recovery and muscle performance. Clinical course and functional measures will be tracked to determine whether armchair positioning adds benefit over staying in bed.

Who should consider this trial

Good fit: Adults on invasive mechanical ventilation for more than 24 hours who are medically stable (RASS > -3), expected to remain in ICU for at least 48 hours, and without contraindications to chair positioning are ideal candidates.

Not a fit: Patients with absolute contraindications to chair positioning (for example recent fractures or orthopedic issues, BMI > 45, advanced sacral pressure injuries), those who are wheelchair-dependent, or those on ECMO are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, early armchair positioning could speed recovery of strength and function and potentially shorten ICU stays for ventilated patients.

How similar studies have performed: Although early mobilization in the ICU has shown benefit in some research, armchair positioning specifically lacks strong high-grade evidence and remains under-tested.

Eligibility criteria

Inclusion Criteria:

1. Patient \> 18 years old
2. Patient on invasive mechanical ventilation for more than 24 hours
3. Patient in recovery phase with a RASS score greater than "-3" for more than 12 hours
4. Stay expected to last 48 hours
5. Patient has never been placed in a chair during this hospitalization in intensive care.
6. Fragility score \< 6, during the month preceding admission to intensive care
7. Patient (or support person/relative if patient is unable to participate) who has agreed to take part in the study.

Exclusion Criteria:

1. Patient with an absolute and non-resolving contraindication to chair positioning

   1. Fracture or orthopedic disorder contraindicating mobilization out of bed
   2. Obesity with body mass index greater than 45 kg/cm2
   3. Sacral eschar stage greater than 2
2. Patient using a wheelchair for mobility (i.e. paraplegic patient or patient with progressive neurological pathology).
3. Patient treated with veno-venous or veno-arterial ECMO at the time of screening.
4. Moribund patient
5. Encephalic death
6. Acute polyradiculoneuritis (Guillain-Barré syndrome)
7. Myasthenia
8. Patient treated by continuous hemodialysis or hemofiltration for more than 72 hours following the onset of awakening.
9. Complete transmetatarsal or higher amputation of one or both lower limbs.
10. Protected person (under guardianship or curatorship)
11. Person under court protection
12. Person not affiliated to a social security scheme
13. Pregnant or breast-feeding woman
14. Patient already included in the study
15. Patient taking part in an interventional clinical study, the aim of which is to show an improvement in functional level on discharge from the intensive care unit or which focuses on the theme of early rehabilitation in the intensive care unit.

Where this trial is running

Orléans, Centre-Val de Loire and 10 other locations

• Centre Hospitalier Universitaire d'Orléans — Orléans, Centre-Val de Loire, France (RECRUITING)
• Hopital Nord Franche Comte — Belfort, France (RECRUITING)
• CHU Clermont Ferrand — Clermont-Ferrand, France (RECRUITING)
• CH de DAX — Dax, France (NOT_YET_RECRUITING)
• CHU de DIJON — Dijon, France (RECRUITING)
• CH Chartres — Le Coudray, France (RECRUITING)
• Ch Du Mans — Le Mans, France (RECRUITING)
• CHI Mont de Marsan — Mont-de-Marsan, France (RECRUITING)
• CH de Saint-Lô — Saint-Lô, France (NOT_YET_RECRUITING)
• Hopital Foch — Suresnes, France (NOT_YET_RECRUITING)
• CHRU de TOURS — Tours, France (RECRUITING)

Study contacts

• Principal investigator: Guillaume FOSSAT — CHU Orléans
• Study coordinator: Guillaume FOSSAT

Conditions: ICU Acquired Weakness, mechanical ventilation, Arm Chair, Sitting, Early mobility