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The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03824262
Enrollment
28
Registered
2019-01-31
Start date
2019-02-04
Completion date
2019-05-04
Last updated
2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temperature Change, Body

Brief summary

The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

Detailed description

The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.

Interventions

DEVICEHICO-VARIOTHERM 550

Warming during perioperative period.

DEVICEMistral-Air Plus forced air warming device

Warming during perioperative period.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Major abdominal surgery in litotomy position * ASA I-II * Anticipated operation time over 1 hour

Exclusion criteria

* Sepsis * Hypothermia * Hyperthermia * Malignant Hyperthermia * Tyroid dysfunction

Design outcomes

Primary

MeasureTime frameDescription
Body temperature-esophageal probePerioperative period-every 15 minutesEsophageal probe used to measure core body temperature

Secondary

MeasureTime frameDescription
Body temperature-skin thermometerPerioperative period-every 15 minutesSkin thermometer used to measure body temperature
Duration of operationPerioperative periodDuration of operation compared with the change in body temperature
Body temperature-tympanic thermometerPerioperative period-every 15 minutesTympanic thermometer used to measure body temperature
Shivering after the operationPostoperative 1st hour every 10 minutesAssessment of shivering after operation in the recovery room with PAS score
Time to extubationThe end of the operationTime to extubation at the end of operation
Blood lossPerioperative periodBlood loss during the perioperative period

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026