Pre-warming Prevents Hypothermia in Elective Cesarean Section

NCT02091466 | Completed Results DMC

• 1 other identifier: 388/08 - FCMSCSP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypothermia; Perioperative Care; Anesthesia; Spinal; Rewarming

Outcome Measures

Primary Outcomes (1)

• Maternal Hypothermia

  Hypothermia was measured by means of tympanic temperatures.

  60 minutes

Study Arms (2)

Pre-warming

ACTIVE COMPARATOR

The intervention is to warm patients before the anesthesia procedure in experimental groups

Device: pre-warming

Control

NO INTERVENTION

Patients received no active warming before the anesthesia procedure in control groups

Interventions

pre-warming DEVICE

warming patients 30 minutes prior to anesthesia

Pre-warming

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women
• between 18 and 40 years of age
• singleton pregnancy
• gestation longer than 37 weeks
• elective cesarean section

You may not qualify if:

• fever and/or infectious conditions
• familial history of potential malignant hyperthermia
• body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2
• thyroid disorders, dysautonomia, Raynaud's syndrome
• patient in labor

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Irmandade Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221020, Brazil

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ricardo Caio Gracco De Bernardis
• Organization: Faculdade de Ciências Médicas da Santa Casa de São Paulo

rcaiog@yahoo.com.br

55-11-21767280

Study Officials

• Ricardo Caio G De Bernardis, M.D. Ph.D

  Irmandade Santa Casa deMisericórdia de São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 2, 2015
• Results First Posted: November 2, 2015

Record last verified: 2014-09

Locations

BR (1)