Clinical Trial: Pre-warming Prevents Hypothermia in Elective Cesarean Section

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

Introduction Body temperature decreasing following the onset of general or regional anesthesia is caused by a core-to-peripheral redistribution of heat, as demonstrated by several previous studies. Perioperative hypothermia and its complications have been widely studied in patients subjected to non-obstetric surgery; however, literature on the obstetric population is rare, although the incidence of intraoperative shivering can be as high as 60% in these patients. A previous study based on the use of forced air-warming unit during the preoperative and intraoperative periods in patients subjected to cesarean delivery observed a lower incidence of hypothermia and shivering in patients given epidural anesthesia when compared to those given spinal anesthesia.

The forced air system is by far the most commonly used intraoperative warming approach and has an admirable safety record. However, the problem with blanket-forced air warming, circulating-water garments, or water mattresses is that it is impossible to change their position on the bed, which can be uncomfortable, especially if the patient is waiting in a sitting position.

The Bair Paws Gown® presents an air warming system that provides patient-controlled comfort warming in the pre and postoperative setting. The same gown offers effective clinical warming during surgery involving the head, neck, knees or extremities. The air-warming flows through the gown, from knees to head or from head to knees, and allows the patient to be seated with gown covering the area between knees and neck.

Therefore, we designed a study to establish the efficacy of a pre-warming system that keeps the garment throughout the perioperative period, without interruption, initiated 30 minutes before the induction of spinal anesthesia for elective c
Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Current Primary Outcome: Maternal Hypothermia [ Time Frame: 60 minutes ]

Original Primary Outcome: Maternal Hypothermia [ Time Frame: 60 minutes ]

Current Secondary Outcome:

Original Secondary Outcome: hemodynamic condition [ Time Frame: 60 minutes ]

Information By: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Dates:
Date Received: March 13, 2014
Date Started: March 2010
Date Completion:
Last Updated: October 1, 2015
Last Verified: September 2014