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Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT02990429
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Warunee Boayam, Siriraj Hospital

Brief Summary:

Perioperative hypothermia is a common problem. It has been defined as a core temperature below 36ºC. The reasons why patient undergoing gynecologic laparoscopic surgery has perioperative hypothermia because the reduced metabolic heat production, redistribution of heat from the core to the periphery and impaired thermoregulation (due to anesthetics), use of cool carbon dioxide gas insufflations and surgical irrigation solution, as well as heat loss due to the cool environment. This perioperative problem has been linked to adverse patient outcomes such as myocardial ischemia as hypothermia increases plasma catecholamine, surgical site infection as hypothermia diminishes wound tissue O2 tension and coagulopathy as hypothermia impairs platelet function.

It claims that perioperative heat loss occurs by radiation (60%), convection (25%) and evaporation (10%). This is caused by the difference between peripheral body and ambient temperature, air circulation around the body and vasodilatation.

In daily practice, most anesthesia personnel warm patient peri-operatively by using force air warmer and intravenous fluid warmer.

This study aimed to compare the difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery by using forced air and intravenous fluid warmer


Condition or disease Intervention/treatment Phase
Hypothermia; Anesthesia Procedure: Forced Air warmer Procedure: Intravenous Fluid Warmer Not Applicable

Detailed Description:

The study was approved from the Siriraj Institutional Review Board (Si-IRB), COA (Certificate of Analysis): Si201/2016 (18/03/2016), and was written informed consent was obtained from all subjects. The study was conducted at the Department of Siriraj Obstetrics and Gynecology.

A total of 90 patients were enrolled in the study between April 2016 and …..2017. All patients underwent general anesthesia for elective gynecologic laparoscopic surgery. Inclusion criteria were patients aged between 18 and 65, elective case, ASA (American Society of Anesthesiologist) physical status class I-III, BMI 25-30 kg/sq.m., surgical time > 90 minutes. Exclusion criteria were the core temperature less than 36ºC or more than 38ºC. Withdrawal or termination criterion was the change of laparoscopic surgery to exploratory laparotomy.

On the day of surgery, participants signed the informed consent and were randomized equally into two groups: A = 45, receiving intraoperative forced air warming and B =45, having intraoperative intravenous fluid via a fluid warmer All patients underwent general anesthesia after application of standard monitors, anesthesia was induced with fentanyl 1-2 mcg/kg or morphine 0.1-0.2 mg/kg., propofol 1.5-2.5 mg/kg, nimbex 1-1.5 mg/kg or atracurium 0.6 mg/kg. Anesthesia was maintained with sevoflurane ,air,O2, supplemented with fentanyl or morphine.

Core temperatures were measured with an electronic thermometer via tympanic membrane. Intraoperatively, core temperatures and room temperatures were measured at 15 minute intervals until the end of surgery .

Postoperative data were measured at 15 minute intervals at the recovery room. Data consisted of vital sign, core temperature, room temperature, shivering, medication requirements and use of heating devices.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparison Between Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery
Study Start Date : April 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Forced Air warmer (bair hugger)

.

In groups: A = 45, receiving intraoperative forced air warming( bair hugger). The forced air was delivered at the high setting of 43ºC

Procedure: Forced Air warmer
  • record room temperature
  • record core temperature (tympanic membrane)
  • General anesthesia
  • using forced air warmer (bair hugger)
  • Intravenous fluid at room temperature
  • room temperature and core temperature q15 minutes
  • anesthesia finish, stop bair hugger
  • record core temperature before recovery room

Experimental: Intravenous Fluid Warmer(ranger warmer)
In groups:B =45, having intraoperative intravenous fluid via a fluid warmer patients received intravenous fluid via a fluid warmer after induction anesthesia. The device automatically heated fluid up to 41ºC as set point.
Procedure: Intravenous Fluid Warmer
  • record room temperature
  • record core temperature (tympanic membrane)
  • General anesthesia
  • using ranger warmer
  • Intravenous fluid at room temperature
  • room temperature and core temperature q15 minutes
  • anesthesia finish, stop ranger warmer
  • record core temperature before recovery room




Primary Outcome Measures :
  1. The difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery (by using forced air and intravenous fluid warmer) [ Time Frame: 1 Year ]
    To study the difference between two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA class 1-3, 18-65 years old, BMI 25-30 kg/sq.m., core temperature 36ºC-38ºC, operation more than 90 minutes

Exclusion Criteria:

  • turn operation to exploratory laparotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990429


Locations
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Thailand
Warunee Boayam
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Investigators
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Principal Investigator: Warunee Boayam, NS Department of Anesthesiology, Faculty of Medicine, Siriraj hospital
  Study Documents (Full-Text)

Documents provided by Warunee Boayam, Siriraj Hospital:

Publications:

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Responsible Party: Warunee Boayam, Faculty of Medicine Siriraj Hospital, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT02990429     History of Changes
Other Study ID Numbers: 050/2559(EC2)
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Warunee Boayam, Siriraj Hospital:
hypothermia
Shivering
Gynecologic laparoscopic surgery
Warming
General anesthesia
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs