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Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

Primary Purpose

Hypothermia; Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Forced Air warmer
Intravenous Fluid Warmer
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypothermia; Anesthesia focused on measuring hypothermia, Shivering, Gynecologic laparoscopic surgery, Warming, General anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Warunee Boayam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Forced Air warmer (bair hugger)

Intravenous Fluid Warmer(ranger warmer)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

The difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery (by using forced air and intravenous fluid warmer)
To study the difference between two groups

Secondary Outcome Measures

Full Information

First Posted
December 3, 2016
Last Updated
April 2, 2019
Sponsor
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02990429
Brief Title
Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery
Official Title
Comparison Between Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
Keywords
hypothermia, Shivering, Gynecologic laparoscopic surgery, Warming, General anesthesia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forced Air warmer (bair hugger)
Arm Type
Experimental
Arm Description
. In groups: A = 45, receiving intraoperative forced air warming( bair hugger). The forced air was delivered at the high setting of 43ºC
Arm Title
Intravenous Fluid Warmer(ranger warmer)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Forced Air warmer
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Intravenous Fluid Warmer
Intervention Description
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 Measure Information:
Title
The difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery (by using forced air and intravenous fluid warmer)
Description
To study the difference between two groups
Time Frame
1 Year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warunee Boayam, NS
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Siriraj hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warunee Boayam
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
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20622611
Citation
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Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

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