Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132154
Enrollment
111
Registered
2019-10-18
Start date
2019-10-15
Completion date
2020-06-23
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inadvertent Perioperative Hypothermia

Keywords

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

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.

Interventions

PROCEDUREConvective Forced-Air Active Warming

Underbody Blanket Model 585 of the 3M BairHugger Series

Sponsors

Institute for Occupational, Social and Environmental Medicine, RWTH Aachen University
CollaboratorUNKNOWN
Department of Anaesthesiology and Intensive Care Medicine, Hospital Düren
CollaboratorUNKNOWN
St. Marien-Hospital Düren
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Hypothermia rate ORThrough completion of the surgical procedure, an average of 1 hourHypothermia 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).
Hypothermia rate RRThrough completion of the postoperative recovery, an average of 2 hoursHypothermia 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

Secondary

MeasureTime frameDescription
Delta_TimeThrough completion of the surgical procedure, an average of 1 hourThe time from the induction of anesthesia to Nadir of temperature values
Delta_TempThrough completion of the surgical procedure, an average of 1 hourTemp= Temperature. Delta\_Temp=The difference between Tmax -Tmin( the maximum and the minimum recorded temperatures)
Delta_recoveryThrough completion of the surgical procedure and the postoperative recovery phase , an average of 3 hourThe time from Tmin (minimum recorded temperature values) to the recovery of 30% of the dropped body core temperature in degrees Celsius.

Other

MeasureTime frameDescription
Newborn BEAt birthFor 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.
Newborn APGAR scoreAt 1, 5 and 10 minutes after birthThe 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.
Newborn pHAt birthFor 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026