Perioperative Warming Measures in Cesarean Delivery

Not Applicable

Recruiting

• Conditions: Hypothermia; Anesthesia; Hypothermia, Sequela; Hypothermia, Newborn
• Interventions: Device: Pre op upper body forced air warming (32˚C); Device: Pre op lower body forced air warming (32˚C); Device: Pre op fluids (45˚C); Device: Intra op upper body forced air warming (32˚C); Device: Intra op upper body forced air warming at (32˚C); Device: Intra op fluids at room temperature; Device: Intra op upper body forced air warming at (42˚C); Device: Intra op lower body forced air warming at (32˚C); Device: Intra op lower body forced air warming at (42˚C); Device: Intra op fluid (42˚C)

• Registration Number: NCT05015582
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-20
• Study Start: 2021-08-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• scheduled for elective cesarean section under neuraxial anesthesia
• singleton pregnancy

Exclusion Criteria

• gestational age of less than 37 week
• emergency cesarean

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Pre op lower body forced air warming (32˚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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Treatment	Pre op fluids (45˚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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Treatment	Intra op upper body forced air warming at (32˚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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Treatment	Pre op upper body forced air warming (32˚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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Control Group	Pre op upper body forced air warming (32˚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
Treatment	Intra op upper body forced air warming (32˚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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Treatment	Intra op lower body forced air warming at (32˚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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Control Group	Intra op upper body forced air warming (32˚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
Control Group	Intra op fluids at room temperature	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
Control Group	Intra op upper body forced air warming at (32˚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
Treatment	Intra op lower body forced air warming 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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Control Group	Pre op lower body forced air warming (32˚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
Treatment	Intra op upper body forced air warming 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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Treatment	Intra op fluid (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 and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Control Group	Pre op fluids (45˚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

Primary Outcome Measures

Name	Time	Method
Change in maternal core body temperature	preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Number of women with hypothermia	preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)	Hypothermia is indicated as core temperature \< 36 °C
Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score	10 minutes after birth	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	10 minutes after birth	determined by lab value
Maternal Coagulopathy	end of surgery (4 hours after anesthesia)	determined by lab value

Secondary Outcome Measures

Name	Time	Method
Degree of shivering (severity)	after administration of meperidine, if it applies (about 30 minutes in PACU)	Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Number of patients that need meperidine	after 30 minutes in PACU
Number of patients that show Maternal thermal comfort	end of surgery (4 hours after anesthesia)	scored form 0-10,a higher number indicating more thermal comfort
Perioperative blood loss	end of surgery (4 hours ater anesthesia)
Hospital Length of Stay	Time of admission to time of discharge (about 72 hours after surgery)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States