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Completed

NCT Number: NCT04132154

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

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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Marien Hospital

Düren, North Rhine-Westphalia, 52353, Germany

About this study

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.

Who can participate

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

  • 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).

Treatment and study plan

Convective Forced-Air Active Warming

Procedure

Underbody Blanket Model 585 of the 3M BairHugger Series

Primary outcomes

  1. Hypothermia rate OR

    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).

  2. Hypothermia rate RR

    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

Secondary outcomes

  1. Delta_Temp

    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)

  2. Delta_Time

    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

  3. Delta_recovery

    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.

Other outcomes

  1. Newborn pH

    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.

  2. Newborn BE

    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.

  3. Newborn APGAR score

    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.

Sponsors and collaborators

Lead sponsor

St. Marien-Hospital Düren

Other

Collaborators

  • RWTH Aachen University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2019
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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