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

• Sponsor: Technische Universität München (Other)
• Overall Status: Completed
• CT.gov ID: NCT03666338
• Collaborator: Massachusetts General Hospital (Other), Università degli Studi di Brescia (Other), Beth Israel Deaconess Medical Center (Other)
• Enrollment: 200
• Arms: 2
• Actual Duration (Months): 54.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Care; Rehabilitation	Other: Early, goal-directed mobilization	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization
• Actual Study Start Date: Jul 11, 2011
• Actual Primary Completion Date: Nov 4, 2015
• Actual Study Completion Date: Feb 4, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early, goal-directed mobilization Early goal-directed mobilization with (1) SOMS algorithm and (2) facilitator	Other: Early, goal-directed mobilization; Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator
No Intervention: Standard of Care Standard of Care regarding mobilization

Outcome Measures

Primary Outcome Measures

1. Functional independence at hospital discharge [At the day of hospital discharge, on average up to 1 month]

   minimal modified functional independence measure score of 8 (Scale ranging from 0-8 with the subdomain locomotion and transfer 0-4 each)

Secondary Outcome Measures

1. average achieved mobility level during the ICU stay [from ICU admission to ICU discharge, on average up to 2 weeks]

   mean achieved SOMS level

2. Functional status at hospital discharge [At the day of hospital discharge, on average up to 1 month]

   minimal modified functional independence measure score (range 0-8) of the subdomains transfer and locomotion with 0-4 each

3. Start to mobilization (SOMS > 0) [Days from ICU admission till first mobilization, approximately up to 5 days]

   Start to mobilization in days (Surgical Optimal Mobilization Scale > 0, ranging from 0 = no mobilization to 4 ambulation)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Technische Universität München
• Massachusetts General Hospital
• Università degli Studi di Brescia
• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Matthias Eikermann, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Stefan Schaller, Specialist Intensive Care, Technische Universität München
• ClinicalTrials.gov Identifier: NCT03666338
• Other Study ID Numbers: SOMS-GCS
• First Posted: Sep 11, 2018
• Last Update Posted: Sep 13, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefan Schaller, Specialist Intensive Care, Technische Universität München: early mobilization

Study Results

No Results Posted as of Sep 13, 2018