Hypothermia
Conditions
Keywords
core temperature, sequential compression device, total intravenous anesthesia
Brief summary
We hypothesized that sequential compression device (SCD) compression system might induce more decreases on core temperature by increasing lower extremity blood flow. And, this study investigated the effects of SCD compression system on body temperature in patients during total intravenous anesthesia (TIVA) with propofol and remifentanil.
Detailed description
Anaesthesia was induced and maintained with propofol and remifentanil. During the surgery, temperature was measured and recorded using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient, respectively.
Interventions
applying sequential compression device during the surgery
DEVICEelastic stockings
applying elastic stockings during the surgery
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA I or II * 20-65 year * patient who undergoing elective thyroidectomy
Exclusion criteria
* coronary occlusive disease * peripheral vascular disease * BMI \> 30 kg/m2 * abnormal thyroid function test * laparoscopic assisted thyroidectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Body Temperature | from baseline record core temperature every 15 minutes up to operative end | Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequential Compression Device Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery | 20 |
| Elastic Stockings Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Sequential Compression Device | Elastic Stockings | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 47.6 years STANDARD_DEVIATION 9.3 | 48.2 years STANDARD_DEVIATION 11.5 | 48 years STANDARD_DEVIATION 10 |
| Region of Enrollment Korea, Republic of | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Core Body Temperature
Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.
Time frame: from baseline record core temperature every 15 minutes up to operative end
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequential Compression Device | Core Body Temperature | baseline value | 36.4 degree C | Standard Deviation 0.42 |
| Sequential Compression Device | Core Body Temperature | end of operation vallue | 35.7 degree C | Standard Deviation 0.43 |
| Elastic Stockings | Core Body Temperature | baseline value | 36.3 degree C | Standard Deviation 0.43 |
| Elastic Stockings | Core Body Temperature | end of operation vallue | 35.6 degree C | Standard Deviation 0.41 |