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Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Suspended
CT.gov ID
NCT05314075
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
25.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is intended to calculate the core body temperature in patients who are having a Cesarean Section (C/S) and are kept warm with an Upper Body Forced Air Warming device (Bair Hugger) or underbody forced air warmer. These warming devices are approved and are a required item in many if not all surgical procedures. They are used daily throughout the hospital. The research question is: Where is the best place to position the warming blanket in pregnant mothers undergoing Cesarean section delivery. The researchers hope to compare post - operative core body temperatures in patients getting an Upper Body forced air device versus those getting an Underbody Body forced air warming device.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Upper Body Forced Air Warming device
  • Procedure: Under Body Forced Air Warming device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Upper Body

Procedure: Upper Body Forced Air Warming device
Patients will have the Bair Hugger placed over the body
Other Names:
  • Bair Hugger

    		•
    Active Comparator: Under body

    Procedure: Under Body Forced Air Warming device
    Patients will have the Bair Hugger placed under the body
    Other Names:
  • Bair Hugger

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Core body temperature [1 hour post surgery]

      Maternal core temperatures will be measured using a temperature sensing Foley catheter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age =/> 18 years

    • Elective non-emergent C-section

    Exclusion Criteria:

    • BMI<18/>35

    • Bleeding Disorders e.g. hemophilia, coagulation abnormality, clotting disorders, bleeding diathesis

    • Perioperative hemorrhage >1500ml

    • Non-Singleton Pregnancies

    • Complicated Pregnancy (e.g. Eclampsia, Pre-eclampsia)

    • Conversion to Emergency C-section

    • Endocrine Pathology- e.g. Thyroid Disease, Insulin Dependent Diabetes

    • Inmates

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Fatoumata Kromah, MD, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT05314075
    Other Study ID Numbers:
    • HM20024184
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Virginia Commonwealth University
    Thermoregulation
    Forced air warming
    upper or lower body forced air cover
    core body temperature

    Study Results

    No Results Posted as of Jul 27, 2022