Perioperative Warming Measures in Cesarean Delivery
Primary Purpose
Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre op upper body forced air warming (32˚C)
Pre op lower body forced air warming (32˚C)
Pre op fluids (45˚C)
Intra op upper body forced air warming (32˚C)
Intra op fluids at room temperature
Intra op upper body forced air warming at (32˚C)
Intra op upper body forced air warming at (42˚C)
Intra op lower body forced air warming at (32˚C)
Intra op lower body forced air warming at (42˚C)
Intra op fluid (42˚C)
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia; Anesthesia
Eligibility Criteria
Inclusion Criteria:
- scheduled for elective cesarean section under neuraxial anesthesia
- singleton pregnancy
Exclusion Criteria:
- gestational age of less than 37 week
- emergency cesarean
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control Group
Arm Description
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Outcomes
Primary Outcome Measures
Change in maternal core body temperature
Number of women with hypothermia
Hypothermia is indicated as core temperature < 36 °C
Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score
Five criteria are scored and each one is scored form 0-2 with a total score of 10, a higher score indicating a better outcome.
Neonate status as determined by Umbilical Artery PH
determined by lab value
Maternal Coagulopathy
determined by lab value
Secondary Outcome Measures
Degree of shivering (severity)
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Number of patients that need meperidine
Degree of shivering (severity)
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Number of patients that need meperidine
Degree of shivering (severity)
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Number of patients that show Maternal thermal comfort
scored form 0-10,a higher number indicating more thermal comfort
Perioperative blood loss
Hospital Length of Stay
Full Information
NCT ID
NCT05015582
First Posted
July 22, 2021
Last Updated
January 6, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05015582
Brief Title
Perioperative Warming Measures in Cesarean Delivery
Official Title
Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
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 purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Intervention Type
Device
Intervention Name(s)
Pre op upper body forced air warming (32˚C)
Intervention Description
Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Intervention Type
Device
Intervention Name(s)
Pre op lower body forced air warming (32˚C)
Intervention Description
lower body forced air warming at ambient (32˚C) for at least 30 minutes
Intervention Type
Device
Intervention Name(s)
Pre op fluids (45˚C)
Intervention Description
fluids from warmed cabinet set at 45˚C
Intervention Type
Device
Intervention Name(s)
Intra op upper body forced air warming (32˚C)
Intervention Description
Use of upper body forced air warming intra-operative at ambient (32˚C)
Intervention Type
Device
Intervention Name(s)
Intra op fluids at room temperature
Intervention Description
IV fluids at room temperature
Intervention Type
Device
Intervention Name(s)
Intra op upper body forced air warming at (32˚C)
Intervention Description
upper body forced air warming intra-operative at ambient (32˚C)
Intervention Type
Device
Intervention Name(s)
Intra op upper body forced air warming at (42˚C)
Intervention Description
upper body forced air warming intra-operative at ambient (42˚C)
Intervention Type
Device
Intervention Name(s)
Intra op lower body forced air warming at (32˚C)
Intervention Description
Lower body forced air warming intra-operative at ambient (32˚C)
Intervention Type
Device
Intervention Name(s)
Intra op lower body forced air warming at (42˚C)
Intervention Description
Lower body forced air warming intra-operative at ambient (42˚C)
Intervention Type
Device
Intervention Name(s)
Intra op fluid (42˚C)
Intervention Description
IV fluids with hotline fluid warmer set at 42˚C
Primary Outcome Measure Information:
Title
Change in maternal core body temperature
Time Frame
preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Title
Number of women with hypothermia
Description
Hypothermia is indicated as core temperature < 36 °C
Time Frame
preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Title
Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score
Description
Five criteria are scored and each one is scored form 0-2 with a total score of 10, a higher score indicating a better outcome.
Time Frame
10 minutes after birth
Title
Neonate status as determined by Umbilical Artery PH
Description
determined by lab value
Time Frame
10 minutes after birth
Title
Maternal Coagulopathy
Description
determined by lab value
Time Frame
end of surgery (4 hours after anesthesia)
Secondary Outcome Measure Information:
Title
Degree of shivering (severity)
Description
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Time Frame
on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
Title
Number of patients that need meperidine
Time Frame
on arrival to PACU [about 4 hours after anesthesia]
Title
Degree of shivering (severity)
Description
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Time Frame
after 30 minutes in PACU
Title
Number of patients that need meperidine
Time Frame
after 30 minutes in PACU
Title
Degree of shivering (severity)
Description
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Time Frame
after administration of meperidine, if it applies (about 30 minutes in PACU)
Title
Number of patients that show Maternal thermal comfort
Description
scored form 0-10,a higher number indicating more thermal comfort
Time Frame
end of surgery (4 hours after anesthesia)
Title
Perioperative blood loss
Time Frame
end of surgery (4 hours ater anesthesia)
Title
Hospital Length of Stay
Time Frame
Time of admission to time of discharge (about 72 hours after surgery)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for elective cesarean section under neuraxial anesthesia
singleton pregnancy
Exclusion Criteria:
gestational age of less than 37 week
emergency cesarean
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Norrell, MD
Phone
(713) 500-6200
Email
Stacy.Norrell@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Norrell, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Norrell, MD
Phone
713-500-6200
Email
Stacy.Norrell@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Perioperative Warming Measures in Cesarean Delivery
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