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

NCT06973746 | Recruiting

• 1 other identifier: CHUO-2024-17
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 11

Brief 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)."

Conditions

ICU Acquired Weakness

Keywords

mechanical ventilation; ICU Acquired Weakness; Arm Chair; Sitting; Early mobility

Outcome Measures

Primary Outcomes (1)

• Functional level on "discharge" from intensive care

  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

  On discharge from intensive care or day 28 (depending on which comes first)

Secondary Outcomes (7)

• ICU Mobility scale

  Day 28

• MRC sum score

  Day 28

• Length of stay in intensive care unit

  Day 28

• Ventilator free days

  Day 28

• Mortality rate

  Day 28

Study Arms (2)

sitting out of bed in an arm-chair position

EXPERIMENTAL

Other: sitting out of bed in an arm-chair position

No chair position

NO INTERVENTION

Interventions

sitting out of bed in an arm-chair position OTHER

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.

sitting out of bed in an arm-chair position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient with an absolute and non-resolving contraindication to chair positioning
• Fracture or orthopedic disorder contraindicating mobilization out of bed
• Obesity with body mass index greater than 45 kg/cm2
• Sacral eschar stage greater than 2
• Patient using a wheelchair for mobility (i.e. paraplegic patient or patient with progressive neurological pathology).
• Patient treated with veno-venous or veno-arterial ECMO at the time of screening.
• Moribund patient
• Encephalic death
• Acute polyradiculoneuritis (Guillain-Barré syndrome)
• Myasthenia
• Patient treated by continuous hemodialysis or hemofiltration for more than 72 hours following the onset of awakening.
• Complete transmetatarsal or higher amputation of one or both lower limbs.
• Protected person (under guardianship or curatorship)
• Person under court protection
• Person not affiliated to a social security scheme

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (11)

Centre Hospitalier Universitaire d'Orléans

Orléans, Centre-Val de Loire, 45067, France

RECRUITING

Hopital Nord Franche Comte

Belfort, France

RECRUITING

CHU Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

CH de DAX

Dax, 40100, France

NOT YET RECRUITING

CHU de DIJON

Dijon, France

RECRUITING

CH Chartres

Le Coudray, 28630, France

RECRUITING

Ch Du Mans

Le Mans, 72037, France

RECRUITING

CHI Mont de Marsan

Mont-de-Marsan, 40012, 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 Officials

• Guillaume FOSSAT

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume FOSSAT

CONTACT

+33238651318; guillaume.fossat@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 15, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (11)