St. Marien Hospital
Düren, North Rhine-Westphalia, 52353, Germany
NCT Number: NCT04132154
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.
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Notify Me18 year–45 year
Female
Observational
Düren, North Rhine-Westphalia, 52353, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Underbody Blanket Model 585 of the 3M BairHugger Series
Time frame: Through completion of the surgical procedure, an average of 1 hour
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).
Time frame: Through completion of the postoperative recovery, an average of 2 hours
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
Time frame: Through completion of the surgical procedure, an average of 1 hour
Temp= Temperature. Delta_Temp=The difference between Tmax -Tmin( the maximum and the minimum recorded temperatures)
Time frame: Through completion of the surgical procedure, an average of 1 hour
The time from the induction of anesthesia to Nadir of temperature values
Time frame: Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour
The time from Tmin (minimum recorded temperature values) to the recovery of 30% of the dropped body core temperature in degrees Celsius.
Time frame: At birth
For 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.
Time frame: At birth
For 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.
Time frame: At 1, 5 and 10 minutes after birth
The 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.
St. Marien-Hospital Düren
Other
Prevention of Hypothermia During Caesarean Section: Forced-air Warming and Continuous Core Temperature Monitoring With Zero-heat-flux
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