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

Not Applicable

Recruiting

• Conditions: ICU Acquired Weakness

• Registration Number: NCT06973746
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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)."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-15
• Status Verified: 2025-07
• Study Start: 2025-07-04
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2028-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 72 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
ICU Mobility scale	Day 28	Maximum level of mobility achieved Minimum value = 0, meaning "no mobility" Maximum value = 10, meaning "walking without assistance"
MRC sum score	Day 28	Presence of muscular weakness acquired in intensive care Minimum value = 0, meaning "no muscular contraction" Maximum value = 60, meaning "normal muscular force"
Length of stay in intensive care unit	Day 28
Ventilator free days	Day 28	Number of days without invasive mechanical ventilation
Mortality rate	Day 28
Total length of hospital stay	Day 28
Mortality	Month 6

Trial Locations

Locations (10)

Centre Hospitalier Universitaire d'Orléans; 🇫🇷 Orléans, Centre Val De Loire, France

Hopital Nord Franche Comte; 🇫🇷 Belfort, France

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

CH de DAX; 🇫🇷 Dax, France

CHU de DIJON; 🇫🇷 Dijon, France

CH Chartres; 🇫🇷 Le Coudray, France

Ch Du Mans; 🇫🇷 Le Mans, France

CHI Mont de Marsan; 🇫🇷 Mont-de-Marsan, France

Hopital Foch; 🇫🇷 Suresnes, France

CHRU de TOURS; 🇫🇷 Tours, France