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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • 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 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
Active Comparator
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
  • 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)

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Stacy Norrell, MD
713-500-6200
Stacy.Norrell@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Stacy Norrell, MD
(713) 500-6200
Stacy.Norrell@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.