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Recruiting NCT06973746

NCT06973746 Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients

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Clinical Trial Summary
NCT ID NCT06973746
Status Recruiting
Phase —
Sponsor Centre Hospitalier Régional d'Orléans
Condition ICU Acquired Weakness
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-07-04
Primary Completion 2028-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
sitting out of bed in an arm-chair position

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 150 participants in total. It began in 2025-07-04 with a primary completion date of 2028-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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)."

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.

Contact & Investigator

Central Contact

Guillaume FOSSAT

✉ guillaume.fossat@chu-orleans.fr

📞 +33238651318

Principal Investigator

Guillaume FOSSAT

PRINCIPAL INVESTIGATOR

CHU Orléans

Frequently Asked Questions

Who can join the NCT06973746 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying ICU Acquired Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06973746 currently recruiting?

Yes, NCT06973746 is actively recruiting participants. Contact the research team at guillaume.fossat@chu-orleans.fr for enrollment information.

Where is the NCT06973746 trial being conducted?

This trial is being conducted at Orléans, France, Belfort, France, Clermont-Ferrand, France, Dax, France and 7 additional locations.

Who is sponsoring the NCT06973746 clinical trial?

NCT06973746 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Guillaume FOSSAT at CHU Orléans. The trial plans to enroll 150 participants.

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