Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients

NCT06973746 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Régional d'Orléans

Phase

Not applicable

Started

2025-07-04

Last updated

2025-12-19

Condition(s) studied

ICU Acquired Weakness

Investigational drug(s) / intervention(s)

sitting out of bed in an arm-chair position

sitting out of bed in an arm-chair position: Once the patient has been awake with a RASS score between -1 and +1 for more than 12 hours, he or she must be placed in a chair (by any means) every day for a minimum of 30 minutes until "discharge" from intensive care (or until D28, depending on which comes first), unless there are transient contraindications. If the patient is unable to signal his or her wish to stop the chair session, the criteria for intolerance will be sought and the patient placed in the chair, but in all cases the chair session will not exceed 4 hours.

Study summary

Chair positioning is one of a series of early mobilization techniques. At present, this technique, which involves moving a patient out of the resuscitation bed, can be performed passively or actively. It does not constitute a rehabilitative act as such, but it is considered in common paradigms as a technique to improve "the patient's breathing and strength".

However, recommendations issued in 2013 by the Society of intensive care physiotherapy and the society "Société de réanimation de langue française (SRLF)", reveal that this chair position cannot be recommended with a high grade.

The aim of the investigators is therefore to break down this early mobilization process in intensive care, to find out whether the armchair is an indispensable tool for improving functional and muscular processes.

The research hypothesis is therefore as follows:

"Early armchairing of the resuscitation patient, improves functional recovery compared to a conservative positioning strategy (sitting in bed)."

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Functional level on "discharge" from intensive care — On discharge from intensive care or day 28 (depending on which comes first)
Functional level at "discharge" from the intensive care unit measured by the Physical Function ICU Test scored (PFIT-s). Minimum value = 0 , meaning worse functionnal status Maximum value = 12, meaning better functionnal status

Trial sites (11)

Facility	City	Region	Status
Centre Hospitalier Universitaire d'Orléans	Orléans	Centre-Val de Loire	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06973746 on ClinicalTrials.gov ↗ ← All trials in France