Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization (SOMS-GCS)

Technical University of Munich

Status: Completed

Conditions: Rehabilitation; Critical Care

Treatments: Other: Early, goal-directed mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT03666338

SOMS-GCS

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Early, goal-directed mobilization

Active Comparator group

Description:

Early goal-directed mobilization with (1) SOMS algorithm and (2) facilitator

Treatment:

Other: Early, goal-directed mobilization

Standard of Care

No Intervention group

Description:

Standard of Care regarding mobilization