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

NCT04132154 | Completed

• 1 other identifier: SMHDN012019
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Inadvertent Perioperative Hypothermia

Keywords

cesarean section; C-Section; Hypothermia; Spinal Anesthesia; caesarean section; zero heat flux technology; active warming

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Delta_Temp

  Through completion of the surgical procedure, an average of 1 hour

• Delta_Time

  Through completion of the surgical procedure, an average of 1 hour

• Delta_recovery

  Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour

Other Outcomes (3)

• Newborn pH

  At birth

• Newborn BE

  At birth

• Newborn APGAR score

  At 1, 5 and 10 minutes after birth

Study Arms (2)

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

Interventions

Convective Forced-Air Active Warming PROCEDURE

Underbody Blanket Model 585 of the 3M BairHugger Series

Active Warming

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Marien-Hospital Düren: lead
• Institute for Occupational, Social and Environmental Medicine, RWTH Aachen University: collaborator
• Department of Anaesthesiology and Intensive Care Medicine, Hospital Düren: collaborator

Study Sites (1)

St. Marien Hospital

Düren, North Rhine-Westphalia, 52353, Germany

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurentiu Marin, MD

  Anaesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiologist

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: October 15, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)