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

NCT03666338 | Completed

• 1 other identifier: SOMS-GCS
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

early mobilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• average achieved mobility level during the ICU stay

  from ICU admission to ICU discharge, on average up to 2 weeks

• Functional status at hospital discharge

  At the day of hospital discharge, on average up to 1 month

• Start to mobilization (SOMS > 0)

  Days from ICU admission till first mobilization, approximately up to 5 days

Study Arms (2)

Early, goal-directed mobilization

ACTIVE COMPARATOR

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

Other: Early, goal-directed mobilization

Standard of Care

NO INTERVENTION

Standard of Care regarding mobilization

Interventions

Early, goal-directed mobilization OTHER

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

Early, goal-directed mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• acute myocardial infarction
• do not have lower part of their legs
• have a rapidly developing neuromuscluar disease
• pregnant
• ruptured or leaking aortic aneurysm

Sponsors & Collaborators

• Technical University of Munich: lead
• Massachusetts General Hospital: collaborator
• Università degli Studi di Brescia: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Related Publications (1)

• 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.

  PMID: 27707496 BACKGROUND

Study Officials

• Matthias Eikermann, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Intensive Care

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 11, 2018
• Study Start: July 11, 2011
• Primary Completion: November 4, 2015
• Study Completion: February 4, 2016
• Last Updated: September 13, 2018

Record last verified: 2018-09