MedTrace Logo

Pre-warming Prevents Hypothermia in Elective Cesarean Section

NCT02091466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-11-02

Study results available
· View outcomes & findings →

Summary

Background: Hypothermia is common during general and regional anesthesia even when active warming measures are taken. The existing literature shows that, in pregnant patients, the use of forced air-warming during cesarean section under spinal anesthesia does not prevent maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in pregnant women subjected to elective cesarean delivery.

Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery. After the anesthesia, the thermal gown was moved from the regular position and placed over the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The following variables were observed: preoperative and operative room temperature, hemoglobin saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure ANCOVA compared temperatures of each group, adjusted for baseline values.

Conditions

  • Hypothermia

Interventions

DEVICE

pre-warming

warming patients 30 minutes prior to anesthesia

Sponsors & Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    lead OTHER

Principal Investigators

  • Ricardo Caio G De Bernardis, M.D. Ph.D · Irmandade Santa Casa deMisericórdia de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT02091466 on ClinicalTrials.gov