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Prewarming Effect in Preventing Perioperative Hypothermia

NCT02422758 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2016-02-08

No results posted yet for this study

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.

Conditions

  • Hypothermia

Interventions

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

Passive Prewarming

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Universidade Estadual de Londrina

    lead OTHER

Principal Investigators

  • Cibele Cristina T Fuganti, RN, MS · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-01-31
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02422758 on ClinicalTrials.gov