Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux
- Conditions
- Inadvertent Perioperative Hypothermia
- Interventions
- Procedure: Convective Forced-Air Active Warming
- Registration Number
- NCT04132154
- Lead Sponsor
- St. Marien-Hospital Düren
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 111
Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Active Warming Convective Forced-Air 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
- Primary Outcome Measures
Name Time Method Hypothermia rate OR 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).
Hypothermia rate RR 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
- Secondary Outcome Measures
Name Time Method Delta_recovery 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.
Delta_Temp 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)
Delta_Time Through completion of the surgical procedure, an average of 1 hour The time from the induction of anesthesia to Nadir of temperature values
Trial Locations
- Locations (1)
St. Marien Hospital
🇩🇪Düren, NRW, Germany