Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Postoperative Hypothermia Clinical Trial

Official title:

Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02837913
• Other study ID #: Pro00039382
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: August 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Postoperative Hypothermia

Intervention

Device:
• VitaHeat underbody heating mattress
Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively

Locations

Country	Name	City	State
United States	Cedars Sinai	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood Loss	Estimated blood loss with and without warming	Documented at the end of 2 hour surgical procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Vitals: Blood Pressure	Vitals: blood pressure as mean arterial pressure	Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals