Perioperative Warming Measures in Cesarean Delivery

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

Conditions

• Hypothermia; Anesthesia
• Hypothermia, Newborn
• Hypothermia, Sequela

Interventions

DEVICE

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

Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes

DEVICE

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

lower body forced air warming at ambient (32˚C) for at least 30 minutes

DEVICE

Pre op fluids (45˚C)

fluids from warmed cabinet set at 45˚C

DEVICE

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

Use of upper body forced air warming intra-operative at ambient (32˚C)

DEVICE

Intra op fluids at room temperature

IV fluids at room temperature

DEVICE

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

upper body forced air warming intra-operative at ambient (32˚C)

DEVICE

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

upper body forced air warming intra-operative at ambient (42˚C)

DEVICE

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

Lower body forced air warming intra-operative at ambient (32˚C)

DEVICE

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

Lower body forced air warming intra-operative at ambient (42˚C)

DEVICE

Intra op fluid (42˚C)

IV fluids with hotline fluid warmer set at 42˚C

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Stacy Norrell, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-23

Primary Completion

2021-12-14

Completion

2021-12-14

FDA Device

Yes

Countries

• United States

Study Locations