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

NCT ID: NCT02994641

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

761 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

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.

Detailed Description

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Conditions

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Motor Activity Muscle Strength Muscle Weakness

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adverse discharge disposition

Patients who were discharged to a skilled nursing facility or died in the hospital

COMA Score Assessment

Intervention Type PROCEDURE

No adverse discharge disposition

Patients who were not discharged to a skilled nursing facility or did not die in the hospital

COMA Score Assessment

Intervention Type PROCEDURE

Interventions

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COMA Score Assessment

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

112 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthias Eikermann

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P002568

Identifier Type: -

Identifier Source: org_study_id