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

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Motor Activity; Muscle Strength
• Intervention / Treatment: Procedure: COMA Score Assessment

• Study Type: Observational
• Enrollment (Actual): 761

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • The Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 112 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study cohort of adult patients who are extubated in two SICUs at Massachusetts General Hospital, Boston.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adverse discharge disposition; Patients who were discharged to a skilled nursing facility or died in the hospital	Procedure: COMA Score Assessment
No adverse discharge disposition; Patients who were not discharged to a skilled nursing facility or did not die in the hospital	Procedure: COMA Score Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse discharge disposition	Within one day after hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU length of stay	Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge
Hospital length of stay	Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge
30-day mortality	Within 30-days after extubation in the ICU or until the day of hospital discharge
Hospital costs	Between the day of hospital admission and the day of hospital discharge
30-day hospital readmission	Within 30 days after discharge from the index hospital stay

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation: Receiver operating curve (ROC) analysis - Acute Physiology and Chronic Health Evaluation II	ROC curve of COMA compared to ROC curve of Acute Physiology and Chronic Health Evaluation (APACHE) II	At the day of admission to the ICU as well as within 72 hours after extubation
Validation: Receiver operating curve (ROC) analysis - Charlson Comorbidity Index	ROC curve of COMA compared to ROC curve of Charlson Comorbidity Index (CCI)	At the day of admission to the ICU as well as within 72 hours after extubation
Validation: Receiver operating curve (ROC) analysis - Richmond Agitation and Sedation Score	ROC curve of COMA compared to ROC curve of Richmond Agitation and Sedation Score (RASS)	Within 72 hours after extubation
Validation: Receiver operating curve (ROC) analysis - Confusion Assessment Method ICU score	ROC curve of COMA compared to ROC curve of Confusion Assessment Method (CAM) ICU score	Within 72 hours after extubation
Validation: weighed kappa statistics	Inter-rater agreement with COMA score between A.M. and P.M. shift nurse	Within 72 hours after extubation
Validation: correlation between COMA and actual skeletal muscle index assessed by computer tomography	Skeletal muscle index is measured at the level of the 3rd lumbar vertebrae	Within 72 hours after extubation

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: critical care; length of stay; patient discharge; hospital mortality; costs and cost analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 2015P002568