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

NCT ID: NCT04132154

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-06-23

Brief Summary

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.

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.

Conditions

Inadvertent Perioperative Hypothermia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

Convective Forced-Air Active Warming

Intervention Type: PROCEDURE

Underbody Blanket Model 585 of the 3M BairHugger Series

Interventions

Convective Forced-Air Active Warming

Underbody Blanket Model 585 of the 3M BairHugger Series

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Occupational, Social and Environmental Medicine, RWTH Aachen University

UNKNOWN

Sponsor Role: collaborator

Department of Anaesthesiology and Intensive Care Medicine, Hospital Düren

UNKNOWN

Sponsor Role: collaborator

St. Marien-Hospital Düren

OTHER

Sponsor Role: lead

Responsible Party

Laurentiu Marin, MD

Anaesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurentiu Marin, MD

Role: PRINCIPAL_INVESTIGATOR

Anaesthesiologist

Locations

St. Marien Hospital

Düren, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

SMHDN012019

Identifier Type: -

Identifier Source: org_study_id