Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
- Conditions
- Postoperative Hypothermia
- Interventions
- Device: VitaHeat underbody heating mattress
- Registration Number
- NCT02837913
- Lead Sponsor
- Cedars-Sinai Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 19
- will be age >18 years,
- singleton pregnancy >37 weeks,
- neuraxial anesthesia,
- healthy afebrile patients.
-
• will be age >18 years,
- singleton pregnancy >37 weeks,
- neuraxial anesthesia,
- healthy afebrile patients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Underbody warmer on VitaHeat underbody heating mattress Underbody warmer will be underneath the patient and turned on. Underbody warmer off VitaHeat underbody heating mattress Underbody warmer will be underneath the patient but not turned on.
- Primary Outcome Measures
Name Time Method Temperature 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit Temperature at time of post anesthesia care unit admission
- Secondary Outcome Measures
Name Time Method Number of Participants With Shivering 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit Shivering at time of post anesthesia care unit admission
Vitals: Heart Rate Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
Blood Loss Documented at the end of 2 hour surgical procedure Estimated blood loss with and without warming
Time to Neonatal Bonding time from delivery to first maternal contact during the 2 hour surgical procedure time to neonatal bonding as skin to skin
Thermal Comfort Visual Analog Scale Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold
Vitals: Oxygen Saturation Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit
Vitals: Blood Pressure Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals Vitals: blood pressure as mean arterial pressure
Trial Locations
- Locations (1)
Cedars Sinai
🇺🇸Los Angeles, California, United States