Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

Hypothermia; Anesthesia Clinical Trial

Official title:

Comparison Between Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990429
• Other study ID #: 050/2559(EC2)
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia

Intervention

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
• 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

Locations

Country	Name	City	State
Thailand	Warunee Boayam	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (16)

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. — View Citation

Allen PB, Salyer SW, Dubick MA, Holcomb JB, Blackbourne LH. Preventing hypothermia: comparison of current devices used by the US Army in an in vitro warmed fluid model. J Trauma. 2010 Jul;69 Suppl 1:S154-61. doi: 10.1097/TA.0b013e3181e45ba5. — View Citation

Bennett J, Ramachandra V, Webster J, Carli F. Prevention of hypothermia during hip surgery: effect of passive compared with active skin surface warming. Br J Anaesth. 1994 Aug;73(2):180-3. — View Citation

Bernthal EM. Inadvertent hypothermia prevention: the anaesthetic nurses' role. Br J Nurs. 1999 Jan 14-27;8(1):17-25. Review. — View Citation

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. — View Citation

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. — View Citation

Brandt S, Oguz R, Hüttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30. — View Citation

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. — View Citation

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

Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. — View Citation

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. — View Citation

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. — View Citation

Rein EB, Filtvedt M, Walløe L, Raeder JC. Hypothermia during laparotomy can be prevented by locally applied warm water and pulsating negative pressure. Br J Anaesth. 2007 Mar;98(3):331-6. Epub 2007 Jan 26. — View Citation

Turner M, Hodzovic I, Mapleson WW. Simulated clinical evaluation of four fluid warming devices*. Anaesthesia. 2006 Jun;61(6):571-5. — View Citation

Wagner K, Swanson E, Raymond CJ, Smith CE. Comparison of two convective warming systems during major abdominal and orthopedic surgery. Can J Anaesth. 2008 Jun;55(6):358-63. doi: 10.1007/BF03021491. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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