Trial Outcomes & Findings for Sequential Compression Device on Body Temperature (NCT NCT01508052)
NCT ID: NCT01508052
Last Updated: 2014-05-05
Results Overview
Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
from baseline record core temperature every 15 minutes up to operative end
Results posted on
2014-05-05
Participant Flow
Participant milestones
| Measure |
Sequential Compression Device
Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery
|
Elastic Stockings
Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery
|
|---|---|---|
|
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
Sequential Compression Device on Body Temperature
Baseline characteristics by cohort
| Measure |
Sequential Compression Device
n=20 Participants
Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery
|
Elastic Stockings
n=20 Participants
Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
48 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline record core temperature every 15 minutes up to operative endCore temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.
Outcome measures
| Measure |
Sequential Compression Device
n=20 Participants
Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery
|
Elastic Stockings
n=20 Participants
Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery
|
|---|---|---|
|
Core Body Temperature
baseline value
|
36.4 degree C
Standard Deviation 0.42
|
36.3 degree C
Standard Deviation 0.43
|
|
Core Body Temperature
end of operation vallue
|
35.7 degree C
Standard Deviation 0.43
|
35.6 degree C
Standard Deviation 0.41
|
Adverse Events
Sequential Compression Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Elastic Stockings
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place