CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
pre-warmingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02091466
NCT02091466N/ACompleted

Pre-warming With Thermal Gown Prevents Maternal Hypothermia in Elective Cesarean Section

Faculdade de Ciências Médicas da Santa Casa de São Paulo·interventional·Posted Mar 19, 2014·Updated Nov 2, 2015

In Brief

A clinical study evaluating pre-warming for Hypothermia. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothermia
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2014
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.3 years ago

Interventions

pre-warmingdevice

warming patients 30 minutes prior to anesthesia