Trial Outcomes & Findings for Effect of Prewarming on Microcirculatory Response (NCT NCT02186210)
NCT ID: NCT02186210
Last Updated: 2019-03-18
Results Overview
We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 hours after induction of anesthesia
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
Prewarming
prewarming during induction of anesthesia
prewarming: recovery slope StO2
|
Control
no prewarming during induction of anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prewarming
n=20 Participants
prewarming during induction of anesthesia
prewarming: recovery slope StO2
|
Control
n=20 Participants
no prewarming during induction of anesthesia
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9 • n=20 Participants
|
66 years
STANDARD_DEVIATION 8 • n=20 Participants
|
65 years
STANDARD_DEVIATION 8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3 hours after induction of anesthesiaWe will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
Outcome measures
| Measure |
Prewarming
n=20 Participants
prewarming during induction of anesthesia
prewarming: recovery slope StO2
|
Control
n=20 Participants
no prewarming during induction of anesthesia
|
|---|---|---|
|
Recovery Slope
|
2.8 % / sec (recovery slope unit)
Standard Deviation 1.0
|
3.1 % / sec (recovery slope unit)
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: During the surgery, an average of 4 hoursOutcome measures
| Measure |
Prewarming
n=20 Participants
prewarming during induction of anesthesia
prewarming: recovery slope StO2
|
Control
n=20 Participants
no prewarming during induction of anesthesia
|
|---|---|---|
|
Tissue Oxygen Saturation
|
76 % (percent of tissue saturation)
Standard Deviation 10
|
79 % (percent of tissue saturation)
Standard Deviation 7
|
Adverse Events
Prewarming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Yunseok Jeon
Seoul National University Hospital Dept of Anesthesiology
Phone: 82-2-2072-2465
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place