Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients
NCT ID: NCT06973746
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-07-04
2028-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
No chair position
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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. 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Guillaume FOSSAT
Role: PRINCIPAL_INVESTIGATOR
CHU Orléans
Locations
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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
CH de Saint-Lô
Saint-Lô, , France
Hopital Foch
Suresnes, , France
CHRU de TOURS
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Guillaume FOSSAT
Role: primary
Valerie CHAUVIN
Role: primary
Angelina BARRAGE
Role: primary
Adrien AUVET, Dr
Role: primary
Jose Arturo PINEDA, Pr
Role: primary
Florence SMIS
Role: primary
Maie-Hélène LEROYER
Role: primary
Arnaud DELAHAYE, Dr
Role: primary
Edouard GAUQUELIN
Role: primary
Matthieu REFFIENNA
Role: primary
Baptiste DARDAINE
Role: primary
Other Identifiers
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CHUO-2024-17
Identifier Type: -
Identifier Source: org_study_id