Clinical trial NCT02994641: Critical Care Observation of Motor Activity (COMA) and SICU Outcomes
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Activity
Muscle Strength
Muscle Weakness
Keywords: critical care
patient discharge
costs and cost analysis
length of stay
hospital mortality
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 761
Sex: ALL
Minimum age (years): 18
Maximum age (years): 112
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study cohort of adult patients who are extubated in two SICUs at Massachusetts General Hospital, Boston.

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.


Eligibility 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

Primary outcomes:
measure: Adverse discharge disposition
timeFrame: Within one day after hospital discharge
Secondary outcomes:
measure: ICU length of stay
timeFrame: Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge
measure: Hospital length of stay
timeFrame: Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge
measure: 30-day mortality
timeFrame: Within 30-days after extubation in the ICU or until the day of hospital discharge
measure: Hospital costs
timeFrame: Between the day of hospital admission and the day of hospital discharge
measure: 30-day hospital readmission
timeFrame: Within 30 days after discharge from the index hospital stay
Other outcomes:
measure: Validation: Receiver operating curve (ROC) analysis - Acute Physiology and Chronic Health Evaluation II
timeFrame: At the day of admission to the ICU as well as within 72 hours after extubation
measure: Validation: Receiver operating curve (ROC) analysis - Charlson Comorbidity Index
timeFrame: At the day of admission to the ICU as well as within 72 hours after extubation
measure: Validation: Receiver operating curve (ROC) analysis - Richmond Agitation and Sedation Score
timeFrame: Within 72 hours after extubation
measure: Validation: Receiver operating curve (ROC) analysis - Confusion Assessment Method ICU score
timeFrame: Within 72 hours after extubation
measure: Validation: weighed kappa statistics
timeFrame: Within 72 hours after extubation
measure: Validation: correlation between COMA and actual skeletal muscle index assessed by computer tomography
timeFrame: Within 72 hours after extubation
Locations:
city: Boston
country: United States
facility: The Massachusetts General Hospital
state: Massachusetts
Study officials:
References: