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Prewarming Effect in Preventing Perioperative Hypothermia

Primary Purpose

Hypothermia

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket
Passive Prewarming
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring hypothermia, perioperative nursing, prewarming, prevention and control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Active Prewarming 3M™ BairHugger™Blanket

    Passive Prewarming

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 8, 2015
    Last Updated
    February 4, 2016
    Sponsor
    Universidade Estadual de Londrina
    Collaborators
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02422758
    Brief Title
    Prewarming Effect in Preventing Perioperative Hypothermia
    Official Title
    Prewarming Effect in Preventing Perioperative Hypothermia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    August 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual de Londrina
    Collaborators
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia
    Keywords
    hypothermia, perioperative nursing, prewarming, prevention and control

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Prewarming 3M™ BairHugger™Blanket
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Passive Prewarming
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket
    Other Intervention Name(s)
    3M™ Bair Hugger™Blanket Model 110
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Passive Prewarming
    Primary Outcome Measure Information:
    Title
    Assess the effect of prewarming in maintaining body temperature of patients undergoing elective gynecologic surgery.
    Description
    The temperature will be evaluated throughout the operation and maintenance will be verified at surgery
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cibele Cristina T Fuganti, RN, MS
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18820248
    Citation
    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.
    Results Reference
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    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.
    Results Reference
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    PubMed Identifier
    20042439
    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.
    Results Reference
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    PubMed Identifier
    23452697
    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.
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    PubMed Identifier
    19239533
    Citation
    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.
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    PubMed Identifier
    14661653
    Citation
    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.
    Results Reference
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    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.
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    Citation
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