Prewarming Effect in Preventing Perioperative Hypothermia

Hypothermia Clinical Trial

Official title:

Prewarming Effect in Preventing Perioperative Hypothermia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02422758
• Other study ID #: 38320814.2.0000.5393
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 8, 2015
• Last updated: February 4, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

Maintaining the patient in the perioperative normothermia is a challenge for surgical and nursing staff. Despite advances in the development of new technologies for the prevention of perioperative hypothermia, this event still happens in the operating room of the health services To prevent patient's body temperature loss, passive and active cutaneous warming methods can be used. Passive methods prevent loss of body heat through the heat transfer block, as blankets, clothes and cotton sheets; however, there is evidence to show that although assist in maintaining body temperature, passive methods alone are not effective.

Active warming methods are effective in keeping the perioperative normothermia. Among the different technologies available we emphasize the circulating water mattress, the forced air warming system and the carbon fiber resistive heating blankets.

Based on these and due to the lack of research in the Brazilian reality on effective measures for the prevention of perioperative hypothermia, among these, prewarming, and the finding guided by the professional experience that just directed investment for the maintenance of body temperature patient in the perioperative period, in health services, justified the conduct of this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

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

Other:
• Passive Prewarming

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina	University of Sao Paulo

References & Publications (19)

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. — View Citation

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.

de Brito Poveda V, Clark AM, Galvão 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. Review. — View Citation

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. — View Citation

Esnaola NF, Cole DJ. Perioperative normothermia during major surgery: is it important? Adv Surg. 2011;45:249-63. Review. — View Citation

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. — View Citation

Galvão 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. Review. — View Citation

Galvão 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. Review. — View Citation

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. — View Citation

Knaepel A. Inadvertent perioperative hypothermia: a literature review. J Perioper Pract. 2012 Mar;22(3):86-90. Review. — View Citation

Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. Review. — View Citation

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. — View Citation

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

Poveda Vde B, Galvão CM. [Hypothermia in the intraoperative period: can it be avoided?]. Rev Esc Enferm USP. 2011 Apr;45(2):411-7. Portuguese. — View Citation

Poveda Vde B, Martinez EZ, Galvão CM. Active cutaneous warming systems to prevent intraoperative hypothermia: a systematic review. Rev Lat Am Enfermagem. 2012 Jan-Feb;20(1):183-91. Review. English, Portuguese, Spanish. — View Citation

TRAMONTINI, C. C.; GRAZIANO, K. U. Controle da hipotermia de pacientes cirúrgicos idosos no intraoperatório: avaliação de duas intervenções de enfermagem1.Revista Latino-Americana de Enfermagem, v.15, n.4, p.626-635, 2007.

Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. — View Citation

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

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes