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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • sitting out of bed in an arm-chair position

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: sitting out of bed in an arm-chair positionExperimental treatment 1 intervention
Group B: No chair positionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Functional level on "discharge" from intensive care

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

Time frame
On discharge from intensive care or day 28 (depending on which comes first)

Secondary outcomes

1

ICU Mobility scale

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

Time frame
Day 28
2

MRC sum score

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

Time frame
Day 28
3

Length of stay in intensive care unit

Time frame
Day 28
4

Ventilator free days

Number of days without invasive mechanical ventilation

Time frame
Day 28

Other outcomes

Sponsors and contacts

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