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

Официальное название

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

Обзор

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)."

Вмешательства

• Другое 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 s

Первичные конечные точки

• Functional level on "discharge" from intensive care [Срок оценки: On discharge from intensive care or day 28 (depending on which comes first)]

Вторичные конечные точки (7)

• ICU Mobility scale [Срок оценки: Day 28]
• MRC sum score [Срок оценки: Day 28]
• Length of stay in intensive care unit [Срок оценки: Day 28]
• Ventilator free days [Срок оценки: Day 28]
• Mortality rate [Срок оценки: Day 28]
• Total length of hospital stay [Срок оценки: Day 28]
• Mortality [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 11 центров

• Centre Hospitalier Universitaire d'Orléans — Orléans
• Hopital Nord Franche Comte — Belfort
• CHU Clermont Ferrand — Clermont-Ferrand
• CH de DAX — Dax
• CHU de DIJON — Dijon
• CH Chartres — Le Coudray
• Ch Du Mans — Le Mans
• CHI Mont de Marsan — Mont-de-Marsan
• … и ещё 3 центра

Идентификаторы

NCT: NCT06973746 · CHUO-2024-17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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