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Prewarming Effect in Preventing Perioperative Hypothermia

Sponsor
Universidade Estadual de Londrina (Other)
Overall Status
Unknown status
CT.gov ID
NCT02422758
Collaborator
University of Sao Paulo (Other)
86
Enrollment
2
Arms
15
Duration (Months)

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Anticipated 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 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Assess the effect of prewarming in maintaining body temperature of patients undergoing elective gynecologic surgery. [intraoperative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universidade Estadual de Londrina
    • University of Sao Paulo

    Investigators

    • Principal Investigator: Cibele Cristina T Fuganti, RN, MS, University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cibele Cristina Tramontini Fuganti, Cibele Cristina Tramontini Fuganti, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02422758
    Other Study ID Numbers:
    • 38320814.2.0000.5393
    First Posted:
    Apr 21, 2015
    Last Update Posted:
    Feb 8, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Cibele Cristina Tramontini Fuganti, Cibele Cristina Tramontini Fuganti, University of Sao Paulo
    hypothermia
    perioperative nursing
    prewarming
    prevention and control
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Feb 8, 2016