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

NCT ID: NCT03666338

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-11
• Study Completion Date: 2016-02-04

Brief Summary

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.

Conditions

Critical Care; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early, goal-directed mobilization

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

Group Type: ACTIVE_COMPARATOR

Early, goal-directed mobilization

Intervention Type: OTHER

Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator

Standard of Care

Standard of Care regarding mobilization

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early, goal-directed mobilization

Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Stefan Schaller

Specialist Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Eikermann, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

References

Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.

Reference Type: BACKGROUND

PMID: 27707496 (View on PubMed)

Other Identifiers

SOMS-GCS

Identifier Type: -

Identifier Source: org_study_id