Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux

Prevention of Hypothermia During Caesarean Section: Forced-air Warming and Continuous Core Temperature Monitoring With Zero-heat-flux

Nowadays, caesarean sections account for about 7% of all surgical procedures worldwide. Over 30% of the patients undergoing a caesarean section experience a fall of the body core temperature under 36°C during the procedure. Following a retrospective cohort design, this study aims to examine the magnitude of hypothermia in the parturient and newborn population as well as the impact and efficiency of forced-air warming on preventing it. The researchers plan to conduct a retrospective analysis of the caesarean section treatment protocol at our institution over a period of 5 months including approximately 300 patients who underwent both elective and emergency caesarean sections.

Study Overview

• Status: Completed
• Conditions: Inadvertent Perioperative Hypothermia
• Intervention / Treatment: Procedure: Convective Forced-Air Active Warming

Detailed Description

This research seeks to address the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections. We will also examine the impact of the maternal hypothermia on the newborn temperatures at the time of partus and also 2 hours after birth. The key research question of this study is whether the use of forced-air warming will significantly lower the hypothermia rates and account for a faster temperature recovery in our parturient patients.

A major contribution of our research is that it provides modern high-resolution, continuous and user-error free thermometry. This is achieved through zero-heat-flux technology and automatically recorded by data-loggers. Also, the heterogeneity of our study population, which has not been attended in previous studies, corresponds to the clinical reality of the most obstetric clinics.

This research could provide new information about the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections, in the concept of bonding the babies to the mother's chest immediately after birth, and derive practical implications on the efficiency of intraoperative warming for the standard clinical routine of the majority of the obstetric clinics.

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Düren, NRW, Germany, 52353
      • St. Marien Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Included will be patients undergoing spinal anaesthesia for elective and emergency caesarean delivery in accordance with our clinical day-to-day operative protocol.

Description

Inclusion Criteria:

Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019

Exclusion Criteria:

• different anaesthesia procedure (e.g. intubation anaesthesia, peridural anaesthesia etc.),
• American Society of Anesthesiologists (ASA) Classification III or higher,
• BMI( Body mass index) >45 kg·m-2,
• patients with incomplete documentation,
• estimated perioperative blood loss > 500ml,
• other perioperative complications (ex. insufficient analgesia and change of anaesthesia procedure).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Warming; Patients in this group were treated according to our institution's old protocol and did not receive any warming intervention during the surgical procedure.
Active Warming; This group will include the patients treated after the implementation of the S3 Guidelines for prevention of hypothermia. For this purpose convective warming through an underbody blanket was used during the surgical procedure	Procedure: Convective Forced-Air Active Warming; Underbody Blanket Model 585 of the 3M BairHugger Series

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothermia rate OR	Hypothermia rate in % intraoperatively. The temperature measurements will be started prior to the induction of the anaesthesia and ended when the patient leaves the OR (operating room).	Through completion of the surgical procedure, an average of 1 hour
Hypothermia rate RR	Hypothermia rate in % in the RR (recovery room). The temperature measurements will be started when the patient enters the RR and ended approximately after 2-3 hours when the patient leaves the RR	Through completion of the postoperative recovery, an average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta_Temp	Temp= Temperature. Delta_Temp=The difference between Tmax -Tmin( the maximum and the minimum recorded temperatures)	Through completion of the surgical procedure, an average of 1 hour
Delta_Time	The time from the induction of anesthesia to Nadir of temperature values	Through completion of the surgical procedure, an average of 1 hour
Delta_recovery	The time from Tmin (minimum recorded temperature values) to the recovery of 30% of the dropped body core temperature in degrees Celsius.	Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn pH	For pH values only samples of umbilical venous blood will be used. point-of-care arterial-blood gas (ABG) devices will be used for testing the samples.	At birth
Newborn BE	For BE (Base excess) values only samples of umbilical venous blood will be used. point-of-care arterial-blood gas (ABG) devices will be used for testing the samples.	At birth
Newborn APGAR score	The international standard APGAR Score will be asserted at 1, 5 and 10 minutes after birth. The minimum score is 0 and the maximum 10, a greater score meaning a better outcome.	At 1, 5 and 10 minutes after birth

Collaborators and Investigators

• Sponsor: St. Marien-Hospital Düren
• Collaborators: Institute for Occupational, Social and Environmental Medicine, RWTH Aachen University; Department of Anaesthesiology and Intensive Care Medicine, Hospital Düren
• Investigators: Principal Investigator: Laurentiu Marin, MD, Anaesthesiologist

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; caesarean section; Hypothermia; Spinal Anesthesia; active warming; C-Section; zero heat flux technology
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: SMHDN012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No