Perioperative Warming Measures in Cesarean Delivery

NCT ID: NCT05015582

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2023-08-01

Brief Summary

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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

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Conditions

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Hypothermia; Anesthesia Hypothermia, Newborn Hypothermia, Sequela

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Pre op fluids (45˚C)

Intervention Type DEVICE

fluids from warmed cabinet set at 45˚C

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Intra op fluid (42˚C)

Intervention Type DEVICE

IV fluids with hotline fluid warmer set at 42˚C

Control Group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Pre op fluids (45˚C)

Intervention Type DEVICE

fluids from warmed cabinet set at 45˚C

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

Intervention Type DEVICE

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

Intra op fluids at room temperature

Intervention Type DEVICE

IV fluids at room temperature

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Pre op fluids (45˚C)

fluids from warmed cabinet set at 45˚C

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Intra op fluids at room temperature

IV fluids at room temperature

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Intra op fluid (42˚C)

IV fluids with hotline fluid warmer set at 42˚C

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* gestational age of less than 37 week
* emergency cesarean
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Stacy Lynn Norrell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stacy Norrell, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stacy Norrell, MD

Role: CONTACT

(713) 500-6200

Facility Contacts

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Stacy Norrell, MD

Role: primary

713-500-6200

Other Identifiers

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HSC-MS-21-0011

Identifier Type: -

Identifier Source: org_study_id

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