Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

The primary aim of the current study will be to determine if the use of an underbody heating mattress during cesarean sections will decrease the incidence of postoperative hypothermia, defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia. As part of the primary outcome the difference in the incidence of shivering, its severity, and need for treatment will be investigated. As a secondary goal other maternal perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to skin' contact. The relationship between maternal hypothermia and newborn outcomes of temperature and APGAR scores will also be evaluated.

Active preoperative and intraoperative warming may prevents inadvertent perioperative hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The underbody warming mattress may be a step towards finding a suitable form of warming that is comfortable for awake patients, does not interfere with skin to skin contact and maternal-fetal bonding.

Study Overview

• Status: Terminated
• Conditions: Postoperative Hypothermia
• Intervention / Treatment: Device: VitaHeat underbody heating mattress

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• will be age >18 years,
• singleton pregnancy >37 weeks,
• neuraxial anesthesia,
• healthy afebrile patients.

Exclusion Criteria:

• • will be age >18 years,

  • singleton pregnancy >37 weeks,
  • neuraxial anesthesia,
  • healthy afebrile patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Underbody warmer on; Underbody warmer will be underneath the patient and turned on.	Device: VitaHeat underbody heating mattress; Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively
Placebo Comparator: Underbody warmer off; Underbody warmer will be underneath the patient but not turned on.	Device: VitaHeat underbody heating mattress; Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	Temperature at time of post anesthesia care unit admission	15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Shivering	Shivering at time of post anesthesia care unit admission	15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit
Vitals: Heart Rate	Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit	Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Blood Loss	Estimated blood loss with and without warming	Documented at the end of 2 hour surgical procedure
Time to Neonatal Bonding	time to neonatal bonding as skin to skin	time from delivery to first maternal contact during the 2 hour surgical procedure
Thermal Comfort Visual Analog Scale	Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold	Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Vitals: Oxygen Saturation	Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit	Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Vitals: Blood Pressure	Vitals: blood pressure as mean arterial pressure	Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Perioperative Warming
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: Pro00039382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No