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

NCT02994641 | Completed

• 1 other identifier: 2015P002568
• Study Type: observational
• Target: 761
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Activity; Muscle Strength; Muscle Weakness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adverse discharge disposition

  Within one day after hospital discharge

Secondary Outcomes (5)

• 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 Outcomes (6)

• Validation: Receiver operating curve (ROC) analysis - Acute Physiology and Chronic Health Evaluation 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

  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

  Within 72 hours after extubation

Study Arms (2)

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

Interventions

COMA Score Assessment PROCEDURE

Adverse discharge disposition; No adverse discharge disposition

Eligibility Criteria

• Age: 18 Years - 112 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Tracheostomy without extubation attempt
• Death without extubation attempt/terminal extubation

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

The Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Motor Activity; Muscle Weakness

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 16, 2016
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)