Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

NCT02990429 | Completed DMC

• 1 other identifier: 050/2559(EC2)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Hypothermia; Anesthesia

Keywords

hypothermia; Shivering; Gynecologic laparoscopic surgery; Warming; General anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  1 Year

Study Arms (2)

Forced Air warmer (bair hugger)

EXPERIMENTAL

. 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

Intravenous Fluid Warmer(ranger warmer)

EXPERIMENTAL

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

Interventions

Forced Air warmer PROCEDURE

* 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

Forced Air warmer (bair hugger)

Intravenous Fluid Warmer PROCEDURE

* 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

Intravenous Fluid Warmer(ranger warmer)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• turn operation to exploratory laparotomy

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Warunee Boayam

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (16)

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  PMID: 20042442 BACKGROUND

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  PMID: 17259258 BACKGROUND

• Feroe DD, Augustine SD. Hypothermia in the PACU. Crit Care Nurs Clin North Am. 1991 Mar;3(1):135-44.

  PMID: 2043323 BACKGROUND

• Witkowski W, Maj J. [Pathophysiology and management of perioperative hypothermia]. Pol Merkur Lekarski. 2006 Jun;20(120):629-34. Polish.

  PMID: 17007255 BACKGROUND

• Turner M, Hodzovic I, Mapleson WW. Simulated clinical evaluation of four fluid warming devices*. Anaesthesia. 2006 Jun;61(6):571-5. doi: 10.1111/j.1365-2044.2006.04589.x.

  PMID: 16704592 BACKGROUND

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  PMID: 10085808 BACKGROUND

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  PMID: 7917732 BACKGROUND

• Borms SF, Engelen SL, Himpe DG, Suy MR, Theunissen WJ. Bair hugger forced-air warming maintains normothermia more effectively than thermo-lite insulation. J Clin Anesth. 1994 Jul-Aug;6(4):303-7. doi: 10.1016/0952-8180(94)90077-9.

  PMID: 7946366 BACKGROUND

• Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. doi: 10.1097/00000542-199403000-00026.

  PMID: 8141463 BACKGROUND

• Bieberich MT, Van Duren AP. Thermal control and design considerations for a high-performance fluid warmer. Biomed Instrum Technol. 2003 Mar-Apr;37(2):103-12. doi: 10.2345/0899-8205(2003)37[103:TCADCF]2.0.CO;2.

  PMID: 12677748 BACKGROUND

• Patel N, Smith CE, Pinchak AC, Hagen JF. Prospective, randomized comparison of the Flotem Iie and Hotline fluid warmers in anesthetized adults. J Clin Anesth. 1996 Jun;8(4):307-16. doi: 10.1016/0952-8180(96)00040-2.

  PMID: 8695135 BACKGROUND

• Presson RG Jr, Bezruczko AP, Hillier SC, McNiece WL. Evaluation of a new fluid warmer effective at low to moderate flow rates. Anesthesiology. 1993 May;78(5):974-80. doi: 10.1097/00000542-199305000-00023.

  PMID: 8489069 BACKGROUND

• Faries G, Johnston C, Pruitt KM, Plouff RT. Temperature relationship to distance and flow rate of warmed i.v. fluids. Ann Emerg Med. 1991 Nov;20(11):1198-200. doi: 10.1016/s0196-0644(05)81470-2.

  PMID: 1952305 BACKGROUND

• Adriani MB, Moriber N. Preoperative forced-air warming combined with intraoperative warming versus intraoperative warming alone in the prevention of hypothermia during gynecologic surgery. AANA J. 2013 Dec;81(6):446-51.

  PMID: 24597006 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Warunee Boayam, NS

  Department of Anesthesiology, Faculty of Medicine, Siriraj hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine Siriraj Hospital

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 13, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 4, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)