We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 422 for:    Coma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02994641
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, 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.

Condition or disease Intervention/treatment
Motor Activity Muscle Strength Muscle Weakness Procedure: COMA Score Assessment

Study Type : Observational
Actual Enrollment : 761 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : December 2012
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Adverse discharge disposition [ Time Frame: Within one day after hospital discharge ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 112 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study cohort of adult patients who are extubated in two SICUs at Massachusetts General Hospital, Boston.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994641


Locations
United States, Massachusetts
The Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Matthias Eikermann, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02994641     History of Changes
Other Study ID Numbers: 2015P002568
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
critical care
patient discharge
costs and cost analysis
length of stay
hospital mortality

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms