Perioperative Warming Measures in Cesarean Delivery

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05015582
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.8
• Patients Per Site Per Month: 21

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hypothermia; Anesthesia; Hypothermia, Newborn; Hypothermia, Sequela	Device: Pre op upper body forced air warming (32˚C); Device: Pre op lower body forced air warming (32˚C); Device: Pre op fluids (45˚C); Device: Intra op upper body forced air warming (32˚C); Device: Intra op fluids at room temperature; Device: Intra op upper body forced air warming at (32˚C); Device: Intra op upper body forced air warming at (42˚C); Device: Intra op lower body forced air warming at (32˚C); Device: Intra op lower body forced air warming at (42˚C); Device: Intra op fluid (42˚C)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery
• Anticipated Study Start Date: Aug 23, 2021
• Anticipated Primary Completion Date: Jan 15, 2022
• Anticipated Study Completion Date: Jan 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Change in maternal core body temperature [preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)]

2. Number of women with hypothermia [preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)]

   Hypothermia is indicated as core temperature < 36 °C

3. Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score [10 minutes after birth]

   Five criteria are scored and each one is scored form 0-2 with a total score of 10, a higher score indicating a better outcome.

4. Neonate status as determined by Umbilical Artery PH [10 minutes after birth]

   determined by lab value

5. Maternal Coagulopathy [end of surgery (4 hours after anesthesia)]

   determined by lab value

Secondary Outcome Measures

1. Degree of shivering (severity) [on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]]

   Degree of shivering is measured from 0(no shivering)-3(total body shivering)

2. Number of patients that need meperidine [on arrival to PACU [about 4 hours after anesthesia]]

3. Degree of shivering (severity) [after 30 minutes in PACU]

   Degree of shivering is measured from 0(no shivering)-3(total body shivering)

4. Number of patients that need meperidine [after 30 minutes in PACU]

5. Degree of shivering (severity) [after administration of meperidine, if it applies (about 30 minutes in PACU)]

   Degree of shivering is measured from 0(no shivering)-3(total body shivering)

6. Number of patients that show Maternal thermal comfort [end of surgery (4 hours after anesthesia)]

   scored form 0-10,a higher number indicating more thermal comfort

7. Perioperative blood loss [end of surgery (4 hours ater anesthesia)]

8. Hospital Length of Stay [Time of admission to time of discharge (about 72 hours after surgery)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Stacy Norrell, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stacy Lynn Norrell, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT05015582
• Other Study ID Numbers: HSC-MS-21-0011
• First Posted: Aug 20, 2021
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• 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: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hypothermia

Study Results

No Results Posted as of Aug 20, 2021