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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Motor Activity, Muscle Strength, Muscle Weakness

Intervention / Treatment
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* Procedure: COMA Score Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 112 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adverse discharge disposition<br>Patients who were discharged to a skilled nursing facility or died in the hospital | Procedure: COMA Score Assessment<br> <br> |
| No adverse discharge disposition<br>Patients who were not discharged to a skilled nursing facility or did not die in the hospital | Procedure: COMA Score Assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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length of stay, critical care, patient discharge, costs and cost analysis, hospital mortality