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

Effect of the Sitting Out of Bed in an Arm-chair Position in ICU on Functional Recovery Among Ventilated Patients: a Prospective Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06973746
Acronym
STORM
Enrollment
150
Registered
2025-05-15
Start date
2025-07-04
Completion date
2028-01-31
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU Acquired Weakness

Keywords

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

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).

Interventions

OTHERsitting 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.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional level on discharge from intensive careOn 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

MeasureTime frameDescription
MRC sum scoreDay 28Presence 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 unitDay 28
Ventilator free daysDay 28Number of days without invasive mechanical ventilation
ICU Mobility scaleDay 28Maximum level of mobility achieved Minimum value = 0, meaning no mobility Maximum value = 10, meaning walking without assistance
Total length of hospital stayDay 28
MortalityMonth 6
Mortality rateDay 28

Countries

France

Contacts

Primary ContactGuillaume FOSSAT
guillaume.fossat@chu-orleans.fr+33238651318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026