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Critical Care Observation of Motor Activity (COMA) and SICU Outcomes

Critical Care Observation of Motor Activity (COMA) - A Practicable and Valid Predictor of Patients' Outcome in the Surgical Intensive Care Unit: A Observational Study at 2 Surgical Intensive Care Units at Massachusetts General Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02994641
Acronym
COMA
Enrollment
761
Registered
2016-12-16
Start date
2012-12-31
Completion date
2014-01-31
Last updated
2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Activity, Muscle Strength, Muscle Weakness

Keywords

critical care, patient discharge, costs and cost analysis, length of stay, hospital mortality

Brief summary

In the surgical intensive care unit (SICU), goals of critical care are often discussed in long-term ventilated patients around the time of extubation. Muscle weakness predicts extubation failure but formal muscle strength assessment by the Medical Research Council scale is time-consuming and not part of the daily clinical exam. In this observational study, we hypothesize that COMA measurement, routinely used by the SICU nurses, is a reliable and valid predictor for patients' SICU outcomes. This prospective observational study is carried out within a consecutively enrolled cohort of adult patients who are extubated in two SICUs at Massachusetts General Hospital, Boston.

Interventions

PROCEDURECOMA Score Assessment

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 112 Years
Healthy volunteers
No

Inclusion criteria

* Intubated and mechanically ventilated patients in 2 ICUs at Massachusetts General Hospital * adult patients

Exclusion criteria

* Tracheostomy without extubation attempt * Death without extubation attempt/terminal extubation

Design outcomes

Primary

MeasureTime frame
Adverse discharge dispositionWithin one day after hospital discharge

Secondary

MeasureTime frame
30-day hospital readmissionWithin 30 days after discharge from the index hospital stay
ICU length of stayTime frame within 24 hours after ICU admission and within 24 hours after ICU discharge
Hospital length of stayTime frame within 24 hours after hospital admission and within 24 hours after hospital discharge
30-day mortalityWithin 30-days after extubation in the ICU or until the day of hospital discharge
Hospital costsBetween the day of hospital admission and the day of hospital discharge

Other

MeasureTime frameDescription
Validation: correlation between COMA and actual skeletal muscle index assessed by computer tomographyWithin 72 hours after extubationSkeletal muscle index is measured at the level of the 3rd lumbar vertebrae
Validation: Receiver operating curve (ROC) analysis - Acute Physiology and Chronic Health Evaluation IIAt the day of admission to the ICU as well as within 72 hours after extubationROC curve of COMA compared to ROC curve of Acute Physiology and Chronic Health Evaluation (APACHE) II
Validation: Receiver operating curve (ROC) analysis - Charlson Comorbidity IndexAt the day of admission to the ICU as well as within 72 hours after extubationROC curve of COMA compared to ROC curve of Charlson Comorbidity Index (CCI)
Validation: Receiver operating curve (ROC) analysis - Richmond Agitation and Sedation ScoreWithin 72 hours after extubationROC curve of COMA compared to ROC curve of Richmond Agitation and Sedation Score (RASS)
Validation: Receiver operating curve (ROC) analysis - Confusion Assessment Method ICU scoreWithin 72 hours after extubationROC curve of COMA compared to ROC curve of Confusion Assessment Method (CAM) ICU score
Validation: weighed kappa statisticsWithin 72 hours after extubationInter-rater agreement with COMA score between A.M. and P.M. shift nurse

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026