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Completed

NCT Number: NCT02994641

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

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.

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Key information

Conditions

Motor Activity Behavior Muscle Strength Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–112 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COMA Score Assessment

Procedure

Primary outcomes

  1. Adverse discharge disposition

    Time frame: Within one day after hospital discharge

Secondary outcomes

  1. ICU length of stay

    Time frame: Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge

  2. Hospital length of stay

    Time frame: Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge

  3. 30-day mortality

    Time frame: Within 30-days after extubation in the ICU or until the day of hospital discharge

  4. Hospital costs

    Time frame: Between the day of hospital admission and the day of hospital discharge

  5. 30-day hospital readmission

    Time frame: Within 30 days after discharge from the index hospital stay

Other outcomes

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

    Time frame: At the day of admission to the ICU as well as within 72 hours after extubation

    ROC curve of COMA compared to ROC curve of Acute Physiology and Chronic Health Evaluation (APACHE) II

  2. Validation: Receiver operating curve (ROC) analysis - Charlson Comorbidity Index

    Time frame: At the day of admission to the ICU as well as within 72 hours after extubation

    ROC curve of COMA compared to ROC curve of Charlson Comorbidity Index (CCI)

  3. Validation: Receiver operating curve (ROC) analysis - Richmond Agitation and Sedation Score

    Time frame: Within 72 hours after extubation

    ROC curve of COMA compared to ROC curve of Richmond Agitation and Sedation Score (RASS)

  4. Validation: Receiver operating curve (ROC) analysis - Confusion Assessment Method ICU score

    Time frame: Within 72 hours after extubation

    ROC curve of COMA compared to ROC curve of Confusion Assessment Method (CAM) ICU score

  5. Validation: weighed kappa statistics

    Time frame: Within 72 hours after extubation

    Inter-rater agreement with COMA score between A.M. and P.M. shift nurse

  6. Validation: correlation between COMA and actual skeletal muscle index assessed by computer tomography

    Time frame: Within 72 hours after extubation

    Skeletal muscle index is measured at the level of the 3rd lumbar vertebrae

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Acronym: COMA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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