Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization

Study Overview
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Brief Summary
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Analysis of the randomized controlled SOMS trial of early, goal-directed mobilization to investigate if the treatment effect is consistent and independent of the initial conscious state without evidence of moderation or modification.

Official Title
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Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization

Conditions
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Critical Care, Rehabilitation

Intervention / Treatment
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* Other: Early, goal-directed mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 years or older mechanically ventilated for less than 48 h and expected to require mechanical ventilation for at least another 24 h at the time of screening functionally independent at baseline with a Barthel Index Score of at least 70 at 2 weeks before admission to the ICU based on patient or proxy completion of the measure Exclusion Criteria: admitted to hospital for more than 5 days before screening a motor component of Glasgow Coma Scale (GCS) lower than 5 irreversible disorder with a 6-month mortality of greater than 50%, raised intracranial pressure cardiopulmonary arrest unstable fractures contributing to probable immobility inclusion in another trial at the same time acute myocardial infarction do not have lower part of their legs have a rapidly developing neuromuscluar disease pregnant ruptured or leaking aortic aneurysm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early, goal-directed mobilization<br>Early goal-directed mobilization with (1) SOMS algorithm and (2) facilitator | Other: Early, goal-directed mobilization<br>* Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator<br>|
| No Intervention: Standard of Care<br>Standard of Care regarding mobilization | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional independence at hospital discharge | minimal modified functional independence measure score of 8 (Scale ranging from 0-8 with the subdomain locomotion and transfer 0-4 each) | At the day of hospital discharge, on average up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average achieved mobility level during the ICU stay | mean achieved SOMS level | from ICU admission to ICU discharge, on average up to 2 weeks | 
| Functional status at hospital discharge | minimal modified functional independence measure score (range 0-8) of the subdomains transfer and locomotion with 0-4 each | At the day of hospital discharge, on average up to 1 month | 
| Start to mobilization (SOMS > 0) | Start to mobilization in days (Surgical Optimal Mobilization Scale > 0, ranging from 0 = no mobilization to 4 ambulation) | Days from ICU admission till first mobilization, approximately up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early mobilization