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OpenTrials
Completed

NCT Number: NCT03824262

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

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.

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Key information

Conditions

Temperature Change, Body Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University School of Medicine Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HICO-VARIOTHERM 550

Device

Warming during perioperative period.

Mistral-Air Plus forced air warming device

Device

Warming during perioperative period.

Primary outcomes

  1. Body temperature-esophageal probe

    Time frame: Perioperative period-every 15 minutes

    Esophageal probe used to measure core body temperature

Secondary outcomes

  1. Body temperature-tympanic thermometer

    Time frame: Perioperative period-every 15 minutes

    Tympanic thermometer used to measure body temperature

  2. Body temperature-skin thermometer

    Time frame: Perioperative period-every 15 minutes

    Skin thermometer used to measure body temperature

  3. Duration of operation

    Time frame: Perioperative period

    Duration of operation compared with the change in body temperature

  4. Blood loss

    Time frame: Perioperative period

    Blood loss during the perioperative period

  5. Shivering after the operation

    Time frame: Postoperative 1st hour every 10 minutes

    Assessment of shivering after operation in the recovery room with PAS score

  6. Time to extubation

    Time frame: The end of the operation

    Time to extubation at the end of operation

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2019
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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