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NCT Number: NCT06973746

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

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)."

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Key information

Conditions

ICU Acquired Weakness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Orléans, Orléans, Centre-Val de Loire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Pregnant or breast-feeding woman
  • Patient already included in the study
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Functional level on "discharge" from intensive care

    Time frame: 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 outcomes

  1. ICU Mobility scale

    Time frame: Day 28

    Maximum level of mobility achieved Minimum value = 0, meaning "no mobility" Maximum value = 10, meaning "walking without assistance"

  2. MRC sum score

    Time frame: Day 28

    Presence of muscular weakness acquired in intensive care Minimum value = 0, meaning "no muscular contraction" Maximum value = 60, meaning "normal muscular force"

  3. Length of stay in intensive care unit

    Time frame: Day 28

  4. Ventilator free days

    Time frame: Day 28

    Number of days without invasive mechanical ventilation

  5. Mortality rate

    Time frame: Day 28

  6. Total length of hospital stay

    Time frame: Day 28

  7. Mortality

    Time frame: Month 6

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume FOSSAT

CONTACT

[email protected]

+33238651318

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: STORM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 15, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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