Perioperative Warming Measures in Cesarean Delivery

The University of Texas System (UT)

Status: Enrolling

Conditions: Hypothermia, Sequela; Hypothermia; Anesthesia; Hypothermia, Newborn

Treatments: Device: Intra op lower body forced air warming at (42˚C); Device: Intra op upper body forced air warming at (32˚C); Device: Pre op fluids (45˚C); Device: Intra op fluids at room temperature; Device: Pre op upper body forced air warming (32˚C); Device: Intra op fluid (42˚C); Device: Intra op upper body forced air warming (32˚C); Device: Intra op upper body forced air warming at (42˚C); Device: Intra op lower body forced air warming at (32˚C); Device: Pre op lower body forced air warming (32˚C)

Study type: Interventional

Funder types: Other

Identifiers

NCT05015582

HSC-MS-21-0011

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• gestational age of less than 37 week
• emergency cesarean

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Treatment

Experimental group

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

Treatment:

Device: Intra op lower body forced air warming at (42˚C)

Device: Intra op upper body forced air warming at (32˚C)

Device: Intra op upper body forced air warming at (42˚C)

Device: Pre op fluids (45˚C)

Device: Pre op lower body forced air warming (32˚C)

Device: Intra op fluid (42˚C)

Device: Intra op upper body forced air warming (32˚C)

Device: Intra op lower body forced air warming at (32˚C)

Device: Pre op upper body forced air warming (32˚C)

Control Group

Active Comparator group

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

Treatment:

Device: Intra op upper body forced air warming at (32˚C)

Device: Pre op fluids (45˚C)

Device: Pre op lower body forced air warming (32˚C)

Device: Intra op fluids at room temperature

Device: Intra op upper body forced air warming (32˚C)

Device: Pre op upper body forced air warming (32˚C)