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NCT05314075 Clinical Trial

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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05314075
Other study ID # HM20024184
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 27, 2022
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Virginia Commonwealth University
Contact Fatoumata Kromah, MD
Phone 804-828-5021
Email fatoumata.kromah@vcuhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 130
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =/> 18 years - Elective non-emergent C-section Exclusion Criteria: - BMI<18/>40 - 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)
Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Core body temperature Maternal core temperatures will be measured using a temperature sensing Foley catheter 1 hour post surgery
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