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
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Device: 3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket Other: Passive Prewarming||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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
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
|Principal Investigator:||Cibele Cristina T Fuganti, RN, MS||University of Sao Paulo|