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Prewarming Effect in Preventing Perioperative Hypothermia

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ClinicalTrials.gov Identifier: NCT02422758
Recruitment Status : Unknown
Verified February 2016 by Cibele Cristina Tramontini Fuganti, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Cibele Cristina Tramontini Fuganti, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Hypothermia Device: 3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket Other: Passive Prewarming Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prewarming Effect in Preventing Perioperative Hypothermia
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Active Prewarming 3M™ BairHugger™Blanket
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
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 Name: 3M™ Bair Hugger™Blanket Model 110

Placebo Comparator: Passive Prewarming
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



Primary Outcome Measures :
  1. Assess the effect of prewarming in maintaining body temperature of patients undergoing elective gynecologic surgery. [ Time Frame: intraoperative ]
    The temperature will be evaluated throughout the operation and maintenance will be verified at surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422758


Sponsors and Collaborators
Universidade Estadual de Londrina
University of Sao Paulo
Investigators
Principal Investigator: Cibele Cristina T Fuganti, RN, MS University of Sao Paulo

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cibele Cristina Tramontini Fuganti, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02422758     History of Changes
Other Study ID Numbers: 38320814.2.0000.5393
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016

Keywords provided by Cibele Cristina Tramontini Fuganti, University of Sao Paulo:
hypothermia
perioperative nursing
prewarming
prevention and control

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms