Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
Primary Purpose
Postoperative Hypothermia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VitaHeat underbody heating mattress
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Hypothermia focused on measuring Perioperative Warming
Eligibility Criteria
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.
Sites / Locations
- Cedars Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Underbody warmer on
Underbody warmer off
Arm Description
Underbody warmer will be underneath the patient and turned on.
Underbody warmer will be underneath the patient but not turned on.
Outcomes
Primary Outcome Measures
Temperature
Temperature at time of post anesthesia care unit admission
Secondary Outcome Measures
Number of Participants With Shivering
Shivering at time of post anesthesia care unit admission
Vitals: Heart Rate
Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
Blood Loss
Estimated blood loss with and without warming
Time to Neonatal Bonding
time to neonatal bonding as skin to skin
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
Vitals: Oxygen Saturation
Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit
Vitals: Blood Pressure
Vitals: blood pressure as mean arterial pressure
Full Information
NCT ID
NCT02837913
First Posted
July 6, 2016
Last Updated
August 26, 2019
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02837913
Brief Title
Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
Official Title
Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting study subjects
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hypothermia
Keywords
Perioperative Warming
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Underbody warmer on
Arm Type
Experimental
Arm Description
Underbody warmer will be underneath the patient and turned on.
Arm Title
Underbody warmer off
Arm Type
Placebo Comparator
Arm Description
Underbody warmer will be underneath the patient but not turned on.
Intervention Type
Device
Intervention Name(s)
VitaHeat underbody heating mattress
Intervention Description
Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively
Primary Outcome Measure Information:
Title
Temperature
Description
Temperature at time of post anesthesia care unit admission
Time Frame
15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Secondary Outcome Measure Information:
Title
Number of Participants With Shivering
Description
Shivering at time of post anesthesia care unit admission
Time Frame
15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit
Title
Vitals: Heart Rate
Description
Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
Time Frame
Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Title
Blood Loss
Description
Estimated blood loss with and without warming
Time Frame
Documented at the end of 2 hour surgical procedure
Title
Time to Neonatal Bonding
Description
time to neonatal bonding as skin to skin
Time Frame
time from delivery to first maternal contact during the 2 hour surgical procedure
Title
Thermal Comfort Visual Analog Scale
Description
Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold
Time Frame
Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Title
Vitals: Oxygen Saturation
Description
Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit
Time Frame
Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Title
Vitals: Blood Pressure
Description
Vitals: blood pressure as mean arterial pressure
Time Frame
Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cedars Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
We'll reach out to this number within 24 hrs