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

Muscle Weakness Clinical Trial

— COMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994641
• Other study ID #: 2015P002568
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 13, 2016
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 112 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Motor Activity
• Muscle Strength
• Muscle Weakness
• Paresis

Intervention

Procedure:
• COMA Score Assessment

Locations

Country	Name	City	State
United States	The Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	Validation: weighed kappa statistics	Inter-rater agreement with COMA score between A.M. and P.M. shift nurse	Within 72 hours after extubation	No
Other	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	No
Primary	Adverse discharge disposition		Within one day after hospital discharge	No
Secondary	ICU length of stay		Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge	No
Secondary	Hospital length of stay		Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge	No
Secondary	30-day mortality		Within 30-days after extubation in the ICU or until the day of hospital discharge	No
Secondary	Hospital costs		Between the day of hospital admission and the day of hospital discharge	No
Secondary	30-day hospital readmission		Within 30 days after discharge from the index hospital stay	No