Perioperative Warming Measures in Cesarean Delivery

Hypothermia; Anesthesia Clinical Trial

Official title:

Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015582
• Other study ID #: HSC-MS-21-0011
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Stacy Norrell, MD
• Phone: (713) 500-6200
• Email: Stacy.Norrell[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• gestational age of less than 37 week
• emergency cesarean

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Newborn
• Hypothermia; Anesthesia

Intervention

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
• Pre op lower body forced air warming (32°C)
lower body forced air warming at ambient (32°C) for at least 30 minutes
• Pre op fluids (45°C)
fluids from warmed cabinet set at 45°C
• Intra op upper body forced air warming (32°C)
Use of upper body forced air warming intra-operative at ambient (32°C)
• Intra op fluids at room temperature
IV fluids at room temperature
• Intra op upper body forced air warming at (32°C)
upper body forced air warming intra-operative at ambient (32°C)
• Intra op upper body forced air warming at (42°C)
upper body forced air warming intra-operative at ambient (42°C)
• Intra op lower body forced air warming at (32°C)
Lower body forced air warming intra-operative at ambient (32°C)
• Intra op lower body forced air warming at (42°C)
Lower body forced air warming intra-operative at ambient (42°C)
• Intra op fluid (42°C)
IV fluids with hotline fluid warmer set at 42°C

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal core body temperature		preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Primary	Number of women with hypothermia	Hypothermia is indicated as core temperature < 36 °C	preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Primary	Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score	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.	10 minutes after birth
Primary	Neonate status as determined by Umbilical Artery PH	determined by lab value	10 minutes after birth
Primary	Maternal Coagulopathy	determined by lab value	end of surgery (4 hours after anesthesia)
Secondary	Degree of shivering (severity)	Degree of shivering is measured from 0(no shivering)-3(total body shivering)	on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
Secondary	Number of patients that need meperidine		on arrival to PACU [about 4 hours after anesthesia]
Secondary	Degree of shivering (severity)	Degree of shivering is measured from 0(no shivering)-3(total body shivering)	after 30 minutes in PACU
Secondary	Number of patients that need meperidine		after 30 minutes in PACU
Secondary	Degree of shivering (severity)	Degree of shivering is measured from 0(no shivering)-3(total body shivering)	after administration of meperidine, if it applies (about 30 minutes in PACU)
Secondary	Number of patients that show Maternal thermal comfort	scored form 0-10,a higher number indicating more thermal comfort	end of surgery (4 hours after anesthesia)
Secondary	Perioperative blood loss		end of surgery (4 hours ater anesthesia)
Secondary	Hospital Length of Stay		Time of admission to time of discharge (about 72 hours after surgery)