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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Critical Care
• Intervention / Treatment: Other: Early, goal-directed mobilization

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Università degli Studi di Brescia
• Investigators: Principal Investigator: Matthias Eikermann, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2011
• Primary Completion (ACTUAL): November 4, 2015
• Study Completion (ACTUAL): February 4, 2016

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: early mobilization
• Other Study ID Numbers: SOMS-GCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: On reasonable request from researchers after an agreement has been found.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No