Critical CareSOMS-GCSNCT03666338
Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization
A study testing Early, goal-directed mobilization in people with Critical Care and Rehabilitation, run by Technical University of Munich.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Rehabilitation
- What is being tested?
- Early, goal-directed mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2011to 4 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- acute myocardial infarction
- do not have lower part of their legs
- have a rapidly developing neuromuscluar disease
- pregnant
- ruptured or leaking aortic aneurysm
Who cannot join
- 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
About this study
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
- Being tested
- Early, goal-directed mobilization
- Keywords
- early mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early, goal-directed mobilizationOther
Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator
| Study group | Role | What they receive |
|---|---|---|
| Early, goal-directed mobilization | Active comparator | Early goal-directed mobilization with (1) SOMS algorithm and (2) facilitator Receives: Other: Early, goal-directed mobilization |
| Standard of Care | No intervention | Standard of Care regarding mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the day of hospital discharge, on average up to 1 month
Secondary outcomes (3)
average achieved mobility level during the ICU stay
mean achieved SOMS level
Measured: 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
Measured: 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)
Measured: Days from ICU admission till first mobilization, approximately up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start11 Jul 2011
- Primary completion4 Nov 2015
- Study completion4 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Università degli Studi di Brescia, Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Stefan Schaller, Technical University of Munich
- Investigators
- Matthias Eikermann, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666338
- Sponsor's protocol ID
- SOMS-GCS
- Acronym
- SOMS-GCS
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On reasonable request from researchers after an agreement has been found.
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.
PubMed 27707496
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization
- ClinicalTrials.gov ID
- NCT03666338
- Acronym / sponsor ID
- SOMS-GCS / SOMS-GCS
- Conditions
- Critical Care, Rehabilitation
- Keywords
- early mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Università degli Studi di Brescia, Beth Israel Deaconess Medical Center
- Study start
- 11 Jul 2011 (actual)
- Primary completion
- 4 Nov 2015 (actual)
- Study completion
- 4 Feb 2016 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early, goal-directed mobilization | Active comparator | Other: Early, goal-directed mobilizationEarly goal-directed mobilization with (1) SOMS algorithm and (2) facilitator |
| Standard of Care | No intervention | –Standard of Care regarding mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- acute myocardial infarction
- do not have lower part of their legs
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early, goal-directed mobilizationEarly, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator | Other | Early, goal-directed mobilization |
Primary outcome
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)
3 secondary outcomes
average achieved mobility level during the ICU stay
Time frame: from ICU admission to ICU discharge, on average up to 2 weeks
Functional status at hospital discharge
Time frame: At the day of hospital discharge, on average up to 1 month
Start to mobilization (SOMS > 0)
Time frame: Days from ICU admission till first mobilization, approximately up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 27707496Schaller 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.
- Individual participant dataSharing planned: Undecided. On reasonable request from researchers after an agreement has been found.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Eikermann, MD principal investigator
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Early, goal-directed mobilization in people with Critical Care and Rehabilitation, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at hospital discharge (time frame: At the day of hospital discharge, on average up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.