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HypothermiaPhase 3NCT02422758

Prewarming Effect in Preventing Perioperative Hypothermia

A Phase 3 study testing 3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket and Passive Prewarming in people with Hypothermia, run by Universidade Estadual de Londrina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Hypothermia
What is being tested?
3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket and Passive Prewarming
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
No sites listed yet
Study dates
May 2015to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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.

Read the detailed 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.

Conditions
Hypothermia
Being tested
3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket, Passive Prewarming
Keywords
hypothermia, perioperative nursing, prewarming, prevention and control
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3M™ Bair Hugger™ Preoperative & Outpatient Care BlanketDevice

    Also called 3M™ Bair Hugger™Blanket Model 110

    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.

  • Passive PrewarmingOther

Study groups in NCT02422758
Study groupRoleWhat they receive
Active Prewarming 3M™ BairHugger™BlanketExperimentalPatients 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.
Receives: Device: 3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket
Passive PrewarmingPlacebo comparatorPassive 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.
Receives: Other: Passive Prewarming

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJan 2016
  4. Study completionAug 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02422758
Sponsor's protocol ID
38320814.2.0000.5393
Status last verified
Feb 2016
First submitted
8 Apr 2015
Last updated
8 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18820248

  • 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 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.

    PubMed 20042439

  • 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.

    PubMed 23452697

  • 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.

    PubMed 19239533

  • 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.

    PubMed 14661653

  • 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.

  • 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.

    PubMed 18262000

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

  • 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.

    PubMed 21126665

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

    PubMed 21988157

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

    PubMed 22493869

  • 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.

    PubMed 17004666

  • 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.

    PubMed 21040819

  • 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.

    PubMed 21655792

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket and Passive Prewarming in people with Hypothermia, run by Universidade Estadual de Londrina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the effect of prewarming in maintaining body temperature of patients undergoing elective gynecologic surgery. (time frame: intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02422758, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016; AzTrials last refreshed its copy on 29 Oct 2026.

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