Trial Outcomes & Findings for The COSMOS Trial. A Pilot Study A Pilot Study (NCT NCT05280574)
NCT ID: NCT05280574
Last Updated: 2025-02-24
Results Overview
The vital sign abnormalities is a 5-component composite including the durations of SpO2 \<85%, heart rate \<45/min, heart rate \>130/min, respiratory rate \<4/min and respiratory rate \>30/min.
COMPLETED
250 participants
Up to 72 hours after surgery
2025-02-24
Participant Flow
Phase 1 enrolled 100 patients with continuous vital sign monitoring blinded to patients and clinicians. Phase 2 randomized 150 patients to either blinded or unblinded continuous monitoring.
Phase 1: A prospective observation cohort phase (no randomization) designed to identify suitable alert thresholds for continuous oxygen saturation, heart rate, and respiratory rate for phase 2. Patient characteristics weren't collected per protocol, ,and analysis was completely qualitative. Phase 2: A randomized trial phase. 176 patients consented, 26 patients withdrew before randomization: * 21 patients went to ICU after surgery * 5 patients declined to attend the study.
Participant milestones
| Measure |
Phase 1 - Prospective Observational Cohort Study: Blinded GE Portrait Monitoring
Patients received continuous vital sign monitoring blinded to patients and clinicians.
Phase 1 was a prospective cohort study without randomization. Patient characteristics weren't collected per protocol, and analysis was completely qualitative.
|
Phase 2 - Randomized Trial: Unblinded GE Portrait Monitoring
Physician investigators monitored and evaluated continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring.
|
Phase 2 - Randomized Trial: Blinded GE Portrait Monitoring
Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
75
|
75
|
|
Overall Study
COMPLETED
|
100
|
73
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 - Prospective Observational Cohort Study: Blinded GE Portrait Monitoring
Patients received continuous vital sign monitoring blinded to patients and clinicians.
Phase 1 was a prospective cohort study without randomization. Patient characteristics weren't collected per protocol, and analysis was completely qualitative.
|
Phase 2 - Randomized Trial: Unblinded GE Portrait Monitoring
Physician investigators monitored and evaluated continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring.
|
Phase 2 - Randomized Trial: Blinded GE Portrait Monitoring
Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Missing data points: 1 for unblinded group and 2 for blinded group
Baseline characteristics by cohort
| Measure |
Phase 2- Randomized Trial: Blinded GE Portrait Monitoring
n=75 Participants
Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals.
|
Phase 2- Randomized Trial: Unblinded GE Portrait Monitoring
n=73 Participants
Physician investigators monitored and evaluated continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring. Patients who are randomized to the unblinded GE Portrait monitoring might be intervened if the clinicians believe that the alarm is clinically meaningful.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 16 • n=75 Participants
|
60 years
STANDARD_DEVIATION 14 • n=73 Participants
|
59 years
STANDARD_DEVIATION 15 • n=148 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=75 Participants
|
41 Participants
n=73 Participants
|
83 Participants
n=148 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=75 Participants
|
32 Participants
n=73 Participants
|
65 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=73 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
61 Participants
n=72 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
123 Participants
n=145 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=73 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
8 Participants
n=72 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
17 Participants
n=145 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=73 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
3 Participants
n=72 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
5 Participants
n=145 Participants • Missing data points: 1 for unblinded group and 2 for blinded group
|
|
Body Mass Index
|
28 kg/m^2
STANDARD_DEVIATION 7.6 • n=74 Participants • Missing data point: 1 for blinded group.
|
28 kg/m^2
STANDARD_DEVIATION 6.2 • n=73 Participants • Missing data point: 1 for blinded group.
|
28 kg/m^2
STANDARD_DEVIATION 7.1 • n=147 Participants • Missing data point: 1 for blinded group.
|
|
American Society of Anesthesiologists (ASA) physical status
Normal
|
1 Participants
n=75 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=148 Participants
|
|
American Society of Anesthesiologists (ASA) physical status
Mild
|
11 Participants
n=75 Participants
|
10 Participants
n=73 Participants
|
21 Participants
n=148 Participants
|
|
American Society of Anesthesiologists (ASA) physical status
Moderate
|
62 Participants
n=75 Participants
|
60 Participants
n=73 Participants
|
122 Participants
n=148 Participants
|
|
American Society of Anesthesiologists (ASA) physical status
Severe
|
1 Participants
n=75 Participants
|
3 Participants
n=73 Participants
|
4 Participants
n=148 Participants
|
|
Smoking status
Never
|
46 Participants
n=70 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
39 Participants
n=70 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
85 Participants
n=140 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
|
Smoking status
Current
|
8 Participants
n=70 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
9 Participants
n=70 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
17 Participants
n=140 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
|
Smoking status
Former (> 6 weeks)
|
16 Participants
n=70 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
22 Participants
n=70 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
38 Participants
n=140 Participants • Missing data point: 5 for blinded group and 3 for unblinded group
|
PRIMARY outcome
Timeframe: Up to 72 hours after surgeryPopulation: Monitor data for one patient in the blinded group was lost so we assumed that AET for all five outcomes were zero.
The vital sign abnormalities is a 5-component composite including the durations of SpO2 \<85%, heart rate \<45/min, heart rate \>130/min, respiratory rate \<4/min and respiratory rate \>30/min.
Outcome measures
| Measure |
Phase 2- Unblinded GE Portrait Monitoring
n=73 Participants
Physician investigators will monitor and evaluate continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring.
|
Phase 2- Blinded GE Portrait Monitoring
n=75 Participants
Continuous vital signs will be monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead will rely on routine vital sign assessments at 4-hour intervals.
|
|---|---|---|
|
Phase 2- Cumulative Duration of Vital Sign Abnormalities
Respiratory rate < 4 breaths/min
|
0 minutes beyond threshold
Interval 0.0 to 0.0
|
0 minutes beyond threshold
Interval 0.0 to 0.0
|
|
Phase 2- Cumulative Duration of Vital Sign Abnormalities
Respiratory rate > 30 breaths/min
|
8.4 minutes beyond threshold
Interval 2.3 to 21.0
|
10 minutes beyond threshold
Interval 2.4 to 20.0
|
|
Phase 2- Cumulative Duration of Vital Sign Abnormalities
Heart rate > 130 beats/min
|
0 minutes beyond threshold
Interval 0.0 to 1.2
|
0 minutes beyond threshold
Interval 0.0 to 0.83
|
|
Phase 2- Cumulative Duration of Vital Sign Abnormalities
SPO2 < 85%
|
6.2 minutes beyond threshold
Interval 1.1 to 17.0
|
4.2 minutes beyond threshold
Interval 0.75 to 37.0
|
|
Phase 2- Cumulative Duration of Vital Sign Abnormalities
Heart rate < 45 beats/min
|
0.02 minutes beyond threshold
Interval 0.0 to 1.1
|
0.42 minutes beyond threshold
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: During postoperative 72 hoursPopulation: We analyzed 73 patients in the unblinded GE Portrait monitoring group, with a total of 73 alarms recorded. Among them, 41 patients experienced no alarms, while the remaining 32 patients accounted for all 73 alarms.
Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group
Outcome measures
| Measure |
Phase 2- Unblinded GE Portrait Monitoring
n=73 Alarms
Physician investigators will monitor and evaluate continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring.
|
Phase 2- Blinded GE Portrait Monitoring
Continuous vital signs will be monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead will rely on routine vital sign assessments at 4-hour intervals.
|
|---|---|---|
|
Phase 2 - Alerts Deemed Meaningful
|
60 Meaningful alarms
|
—
|
SECONDARY outcome
Timeframe: During postoperative 72 hoursPopulation: We analyzed 73 patients in the unblinded GE Portrait monitoring group, with a total of 73 alarms recorded. Among them, 41 patients experienced no alarms, while the remaining 32 patients accounted for all 73 alarms. Out of the 73 alarms, 60 alarms were categorized as informative, important, or critical by the responsible nurse.
Number of clinical interventions by the three categories of meaningful alarms (informative, important, and critical). An investigator will ask the relevant clinician (usually a nurse) to rate each alert as clinically meaningful or not. Specifically, clinicians will be asked to rate alerts as "critical," "important," "informative," or "false or distracting." The terms will intentionally not be further defined, thereby allowing caregivers to determine themselves the extent to which a given alert was helpful or not. Caregivers will be queried in person shortly after each alert, typically within 15 minutes. The thresholds, determined in the initial phase, will be set to generate an average of about 2 alerts per patient per day - and therefore will not be onerous for clinicians.
Outcome measures
| Measure |
Phase 2- Unblinded GE Portrait Monitoring
n=60 Meaningful alarms
Physician investigators will monitor and evaluate continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring.
|
Phase 2- Blinded GE Portrait Monitoring
Continuous vital signs will be monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead will rely on routine vital sign assessments at 4-hour intervals.
|
|---|---|---|
|
Phase 2 - Clinical Interventions to Meaningful Alarms
Informative alarm
|
10 Meaningful alarms
|
—
|
|
Phase 2 - Clinical Interventions to Meaningful Alarms
Important alarm
|
21 Meaningful alarms
|
—
|
|
Phase 2 - Clinical Interventions to Meaningful Alarms
Critical alarm
|
2 Meaningful alarms
|
—
|
Adverse Events
Phase 1 - Prospective Observational Cohort Study: Blinded GE Portrait Monitoring
Phase 2- Randomized Trial: Unblinded GE Portrait Monitoring
Phase 2- Randomized Trial: Blinded GE Portrait Monitoring
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Daniel I. Sessler MD, Professor and Michael Cudahy Chair
Outcomes Research Consortium, Department of Anesthesiology, Cleveland Clinic, Cleveland, Ohio
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place