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

Inadvertent Perioperative Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132154
• Other study ID #: SMHDN012019
• Status: Completed
• Start date: October 15, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: May 2021
• Source: St. Marien-Hospital Düren
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypothermia
• Inadvertent Perioperative Hypothermia

Intervention

Procedure:
• Convective Forced-Air Active Warming
Underbody Blanket Model 585 of the 3M BairHugger Series

Locations

Country	Name	City	State
Germany	St. Marien Hospital	Düren	NRW

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Newborn pH	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.	At birth
Other	Newborn BE	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.	At birth
Other	Newborn APGAR score	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.	At 1, 5 and 10 minutes after birth
Primary	Hypothermia rate OR	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).	Through completion of the surgical procedure, an average of 1 hour
Primary	Hypothermia rate RR	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	Through completion of the postoperative recovery, an average of 2 hours
Secondary	Delta_Temp	Temp= Temperature. Delta_Temp=The difference between Tmax -Tmin( the maximum and the minimum recorded temperatures)	Through completion of the surgical procedure, an average of 1 hour
Secondary	Delta_Time	The time from the induction of anesthesia to Nadir of temperature values	Through completion of the surgical procedure, an average of 1 hour
Secondary	Delta_recovery	The time from Tmin (minimum recorded temperature values) to the recovery of 30% of the dropped body core temperature in degrees Celsius.	Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour