Motor ActivityCOMANCT02994641
Critical Care Observation of Motor Activity (COMA) and SICU Outcomes
An observational study of Motor Activity and Muscle Strength, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 112 years
- Conditions the study is for
- Motor Activity, Muscle Strength, Muscle Weakness
- What is being tested?
- COMA Score Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 761 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 112 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study cohort of adult patients who are extubated in two SICUs at Massachusetts General Hospital, Boston.
Who may be able to join
- Intubated and mechanically ventilated patients in 2 ICUs at Massachusetts General Hospital
- adult patients
Who cannot join
- Tracheostomy without extubation attempt
- Death without extubation attempt/terminal extubation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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
- Being tested
- COMA Score Assessment
- Keywords
- critical care, patient discharge, costs and cost analysis, length of stay, hospital mortality
- Medical subject headings
- Motor Activity, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMA Score AssessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adverse discharge disposition | Patients who were discharged to a skilled nursing facility or died in the hospital Receives: 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 Receives: Procedure: COMA Score Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse discharge disposition
Measured: Within one day after hospital discharge
Secondary outcomes (5)
ICU length of stay
Measured: Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge
Hospital length of stay
Measured: Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge
30-day mortality
Measured: Within 30-days after extubation in the ICU or until the day of hospital discharge
Hospital costs
Measured: Between the day of hospital admission and the day of hospital discharge
30-day hospital readmission
Measured: Within 30 days after discharge from the index hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994641
- Sponsor's protocol ID
- 2015P002568
- Acronym
- COMA
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02994641
- Acronym / sponsor ID
- COMA / 2015P002568
- Conditions
- Motor Activity, Muscle Strength, Muscle Weakness
- Keywords
- critical care, patient discharge, costs and cost analysis, length of stay, hospital mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adverse discharge disposition | – | Procedure: COMA Score AssessmentPatients who were discharged to a skilled nursing facility or died in the hospital |
| No adverse discharge disposition | – | Procedure: COMA Score AssessmentPatients who were not discharged to a skilled nursing facility or did not die in the hospital |
Who may qualify
- Ages
- 18 to 112 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study cohort of adult patients who are extubated in two SICUs at Massachusetts General Hospital, Boston.
Key inclusion criteria (2 listed)
- Intubated and mechanically ventilated patients in 2 ICUs at Massachusetts General Hospital
- adult patients
Key exclusion criteria (2 listed)
- Tracheostomy without extubation attempt
- Death without extubation attempt/terminal extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMA Score Assessment | Procedure or surgery | Adverse discharge disposition, No adverse discharge disposition |
Primary outcome
Adverse discharge disposition
Time frame: Within one day after hospital discharge
5 secondary outcomes
ICU length of stay
Time frame: Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge
Hospital length of stay
Time frame: Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge
30-day mortality
Time frame: Within 30-days after extubation in the ICU or until the day of hospital discharge
Hospital costs
Time frame: Between the day of hospital admission and the day of hospital discharge
30-day hospital readmission
Time frame: Within 30 days after discharge from the index hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
Related trials for Motor Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Activity and Muscle Strength, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse discharge disposition (time frame: Within one day after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.