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

S

St. Marien-Hospital Düren

Status

Completed

Conditions

Inadvertent Perioperative Hypothermia

Treatments

Procedure: Convective Forced-Air Active Warming

Study type

Observational

Funder types

Other

Identifiers

NCT04132154
SMHDN012019

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

111 participants in 2 patient groups

No Warming
Description:
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
Description:
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
Treatment:
Procedure: Convective Forced-Air Active Warming

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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