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

Completed

• Conditions: Muscle Strength; Muscle Weakness; Motor Activity
• Interventions: Procedure: COMA Score Assessment

• Registration Number: NCT02994641
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-16
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 761

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse discharge disposition	COMA Score Assessment	Patients who were discharged to a skilled nursing facility or died in the hospital
No adverse discharge disposition	COMA Score Assessment	Patients who were not discharged to a skilled nursing facility or did not die in the hospital

Primary Outcome Measures

Name	Time	Method
Adverse discharge disposition	Within one day after hospital discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States