Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Conditions
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Postoperative Hypothermia

Intervention / Treatment
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* Device: VitaHeat underbody heating mattress


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative Warming