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OpenTrials
Completed

NCT Number: NCT03666338

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

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.

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Key information

Conditions

Critical Care Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early, goal-directed mobilization

Other

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

Primary outcomes

  1. Functional independence at hospital discharge

    Time frame: 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 outcomes

  1. average achieved mobility level during the ICU stay

    Time frame: from ICU admission to ICU discharge, on average up to 2 weeks

    mean achieved SOMS level

  2. Functional status at hospital discharge

    Time frame: 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

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

Registry information

Acronym: SOMS-GCS

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Sep 11, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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