Clinical trial NCT04132154: Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux
Official title: Prevention of Hypothermia During Caesarean Section: Forced-air Warming and Continuous Core Temperature Monitoring With Zero-heat-flux
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inadvertent Perioperative Hypothermia
Keywords: cesarean section
C-Section
Hypothermia
Spinal Anesthesia
caesarean section
zero heat flux technology
active warming
Lead sponsor: St. Marien-Hospital Düren
Sponsor class: OTHER
Collaborators: name: Institute for Occupational, Social and Environmental Medicine, RWTH Aachen University
name: Department of Anaesthesiology and Intensive Care Medicine, Hospital Düren
First posted: 2019-10-18
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Hypothermia rate OR
timeFrame: Through completion of the surgical procedure, an average of 1 hour
measure: Hypothermia rate RR
timeFrame: Through completion of the postoperative recovery, an average of 2 hours
Secondary outcomes:
measure: Delta_Temp
timeFrame: Through completion of the surgical procedure, an average of 1 hour
measure: Delta_Time
timeFrame: Through completion of the surgical procedure, an average of 1 hour
measure: Delta_recovery
timeFrame: Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour
Other outcomes:
measure: Newborn pH
timeFrame: At birth
measure: Newborn BE
timeFrame: At birth
measure: Newborn APGAR score
timeFrame: At 1, 5 and 10 minutes after birth
Locations:
city: Düren
country: Germany
facility: St. Marien Hospital
state: NRW
Study officials:
affiliation: Anaesthesiologist
name: Laurentiu Marin, MD
role: PRINCIPAL_INVESTIGATOR
References: