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

Rehabilitation Clinical Trial

— SOMS-GCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666338
• Other study ID #: SOMS-GCS
• Status: Completed
• Phase: N/A
• Start date: July 11, 2011
• Est. completion date: February 4, 2016

Study information

• Verified date: September 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 4, 2016
• Est. primary completion date: November 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Rehabilitation

Intervention

Other:
• Early, goal-directed mobilization
Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Technische Universität München	Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Università degli Studi di Brescia

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	average achieved mobility level during the ICU stay	mean achieved SOMS level	from ICU admission to ICU discharge, on average up to 2 weeks
Secondary	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
Secondary	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