Prewarming Effect in Preventing Perioperative Hypothermia

NCT02422758 | Unknown Phase 3 DMC

• 1 other identifier: 38320814.2.0000.5393
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Perioperative hypothermia brings numerous and recognized postoperative complications. Active warming intraoperatively helps to maintain body temperature in the postoperative period, but there are few studies in Brazil, assessing the effect of prewarming in maintaining normothermia. It is believed that prewarming with forced air warming system keep the body temperature during intra and post-operative. This study aims to evaluate the effect on prewarming maintaining body temperature of patients undergoing elective surgery of Gynecology specialty using the forced air warming system. The study is experimental design, controlled type randomized clinical trial, with simple blinding for patients. Eighty adult patients undergoing gynecological surgery in the art, with a surgical time of at least an hour will be randomized and allocated into experimental groups - prewarming system with forced air warming system for 20 minutes, and control - Prewarming with sheet and blanket for 20 minutes. The patients will be kept warm during the anesthetic-surgical procedure. The measurement of temperature will be using a tympanic thermometer. Participants will be followed from receiving the surgical center to the end of surgery. Data will be recorded in validated instrument. Data analysis will be used the Model Linear Mixed Effects and the Structure Error Auto-Regressive.

Conditions

Hypothermia

Keywords

hypothermia; perioperative nursing; prewarming; prevention and control

Outcome Measures

Primary Outcomes (1)

• Assess the effect of prewarming in maintaining body temperature of patients undergoing elective gynecologic surgery.

  The temperature will be evaluated throughout the operation and maintenance will be verified at surgery

  intraoperative

Study Arms (2)

Active Prewarming 3M™ BairHugger™Blanket

EXPERIMENTAL

Patients will have the whole body covered with the3M™ Bair Hugger™ Preoperative \& Outpatient Care Blanket of forced air warming system for 20 minutes, at average power.Tympanic temperature will be measured, through electronic infrared tympanic thermometer GENIUS 2. Patients will be warmed with 3M™ Bair Hugger™ Upper Body Blanket, during intraoperative period.

Device: 3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket

Passive Prewarming

PLACEBO COMPARATOR

Passive prewarming with a cotton sheet and blanket for 20 minutes. Tympanic temperature will be measured, through electronic infrared tympanic thermometer GENIUS 2. Patients will be warmed with 3M™ Bair Hugger™ Upper Body Blanket, during intraoperative period.

Other: Passive Prewarming

Interventions

3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket DEVICE

3M™ Bair Hugger™Preoperative \& Outpatient Care Blanket will cover the whole body. Patients will be prewarmed for 20 minutes with forced air warming system. Unit will be at average power.

Also known as: 3M™ Bair Hugger™Blanket Model 110

Active Prewarming 3M™ BairHugger™Blanket

Passive Prewarming OTHER

Passive Prewarming

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years;
• Undergoing elective surgery with duration of at least one hour in the gynecological specialty with open technique;
• Under general, regional or combined anesthesia.

You may not qualify if:

• Patients with a body temperature above or below 36oC 37,5oC at the reception of the operating room.

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead
• University of Sao Paulo: collaborator

Related Publications (20)

• Andrzejowski J, Hoyle J, Eapen G, Turnbull D. Effect of prewarming on post-induction core temperature and the incidence of inadvertent perioperative hypothermia in patients undergoing general anaesthesia. Br J Anaesth. 2008 Nov;101(5):627-31. doi: 10.1093/bja/aen272. Epub 2008 Sep 26.

  PMID: 18820248 BACKGROUND

• ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES (AORN). Recommended practices for the prevention of unplanned perioperative hypothermia. In: ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES. Perioperative standards and recommended practices. Denver (USA): Association of periOpertive Registered Nurses; 2009.p. 491-504.

  BACKGROUND

• De Witte JL, Demeyer C, Vandemaele E. Resistive-heating or forced-air warming for the prevention of redistribution hypothermia. Anesth Analg. 2010 Mar 1;110(3):829-33. doi: 10.1213/ANE.0b013e3181cb3ebf. Epub 2009 Dec 30.

  PMID: 20042439 BACKGROUND

• Fettes S, Mulvaine M, Van Doren E. Effect of preoperative forced-air warming on postoperative temperature and postanesthesia care unit length of stay. AORN J. 2013 Mar;97(3):323-8. doi: 10.1016/j.aorn.2012.12.011.

  PMID: 23452697 BACKGROUND

• Galvao CM, Marck PB, Sawada NO, Clark AM. A systematic review of the effectiveness of cutaneous warming systems to prevent hypothermia. J Clin Nurs. 2009 Mar;18(5):627-36. doi: 10.1111/j.1365-2702.2008.02668.x.

  PMID: 19239533 BACKGROUND

• Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. doi: 10.1016/s1521-6896(03)00049-1.

  PMID: 14661653 BACKGROUND

• Tramontini CC, Graziano KU. Hypothermia control in elderly surgical patients in the intraoperative period: evaluation of two nursing interventions. Rev Lat Am Enfermagem. 2007 Jul-Aug;15(4):626-31. doi: 10.1590/s0104-11692007000400016.

  PMID: 17923980 BACKGROUND

• Weirich TL. Hypothermia/warming protocols: why are they not widely used in the OR? AORN J. 2008 Feb;87(2):333-44. doi: 10.1016/j.aorn.2007.08.021.

  PMID: 18262000 BACKGROUND

• NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE). Clinical practice guideline - The management of inadvertent perioperative hypothermia in adults. 2008, 567p.

  BACKGROUND

• Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.

  PMID: 21126665 BACKGROUND

• Wartzek T, Muhlsteff J, Imhoff M. Temperature measurement. Biomed Tech (Berl). 2011 Oct;56(5):241-57. doi: 10.1515/BMT.2011.108.

  PMID: 21988157 BACKGROUND

• Knaepel A. Inadvertent perioperative hypothermia: a literature review. J Perioper Pract. 2012 Mar;22(3):86-90. doi: 10.1177/175045891202200302.

  PMID: 22493869 BACKGROUND

• Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.

  PMID: 17004666 BACKGROUND

• Lynch S, Dixon J, Leary D. Reducing the risk of unplanned perioperative hypothermia. AORN J. 2010 Nov;92(5):553-62; quiz 563-5. doi: 10.1016/j.aorn.2010.06.015.

  PMID: 21040819 BACKGROUND

• Poveda Vde B, Galvao CM. [Hypothermia in the intraoperative period: can it be avoided?]. Rev Esc Enferm USP. 2011 Apr;45(2):411-7. doi: 10.1590/s0080-62342011000200016. Portuguese.

  PMID: 21655792 BACKGROUND

• Galvao CM, Liang Y, Clark AM. Effectiveness of cutaneous warming systems on temperature control: meta-analysis. J Adv Nurs. 2010 Jun;66(6):1196-206. doi: 10.1111/j.1365-2648.2010.05312.x.

  PMID: 20546353 BACKGROUND

• Esnaola NF, Cole DJ. Perioperative normothermia during major surgery: is it important? Adv Surg. 2011;45:249-63. doi: 10.1016/j.yasu.2011.03.007.

  PMID: 21954692 BACKGROUND

• POVEDA, V. B.; MARTINEZ, E. Z.; GALVÃO, C. M. Métodos ativos de aquecimento para a prevenção de hipotermia no período intraoperatório: revisão sistemática. Rev. Latino-Am. Enfermagem, v.20, n.1, p. 183-191, 2012.

  BACKGROUND

• de Brito Poveda V, Clark AM, Galvao CM. A systematic review on the effectiveness of prewarming to prevent perioperative hypothermia. J Clin Nurs. 2013 Apr;22(7-8):906-18. doi: 10.1111/j.1365-2702.2012.04287.x. Epub 2012 Sep 17.

  PMID: 22978458 BACKGROUND

• Fuganti CCT, Martinez EZ, Galvao CM. Effect of preheating on the maintenance of body temperature in surgical patients: a randomized clinical trial. Rev Lat Am Enfermagem. 2018 Oct 25;26:e3057. doi: 10.1590/1518-8345.2559.3057.

  PMID: 30379244 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Cibele Cristina T Fuganti, RN, MS

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cibele Cristina Tramontini Fuganti

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 21, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02