Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery
NCT ID: NCT02990429
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2016-04-30
2018-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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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
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(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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Siriraj Hospital
OTHER
Responsible Party
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Warunee Boayam
Faculty of Medicine Siriraj Hospital
Principal Investigators
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Warunee Boayam, NS
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Faculty of Medicine, Siriraj hospital
Locations
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Warunee Boayam
Bangkok Noi, Bangkok, Thailand
Countries
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References
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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.
Brandt S, Oguz R, Huttner 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.
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.
Rein EB, Filtvedt M, Walloe 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. doi: 10.1093/bja/ael369. Epub 2007 Jan 26.
Feroe DD, Augustine SD. Hypothermia in the PACU. Crit Care Nurs Clin North Am. 1991 Mar;3(1):135-44.
Witkowski W, Maj J. [Pathophysiology and management of perioperative hypothermia]. Pol Merkur Lekarski. 2006 Jun;20(120):629-34. Polish.
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.
Bernthal EM. Inadvertent hypothermia prevention: the anaesthetic nurses' role. Br J Nurs. 1999 Jan 14-27;8(1):17-25. doi: 10.12968/bjon.1999.8.1.17.
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. doi: 10.1093/bja/73.2.180.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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050/2559(EC2)
Identifier Type: -
Identifier Source: org_study_id
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