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Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Not Applicable
Terminated
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
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Underbody warmer onVitaHeat underbody heating mattressUnderbody warmer will be underneath the patient and turned on.
Underbody warmer offVitaHeat underbody heating mattressUnderbody warmer will be underneath the patient but not turned on.
Primary Outcome Measures
NameTimeMethod
Temperature15 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
NameTimeMethod
Number of Participants With Shivering15 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 RatePreop 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 LossDocumented at the end of 2 hour surgical procedure

Estimated blood loss with and without warming

Time to Neonatal Bondingtime from delivery to first maternal contact during the 2 hour surgical procedure

time to neonatal bonding as skin to skin

Thermal Comfort Visual Analog ScalePreop 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 SaturationPreop 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 PressurePreop 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

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