Inadvertent Perioperative HypothermiaNCT04132154
Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux
An observational study of Inadvertent Perioperative Hypothermia, run by St. Marien-Hospital Düren at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inadvertent Perioperative Hypothermia
- What is being tested?
- Convective Forced-Air Active Warming
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2019to 23 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Included will be patients undergoing spinal anaesthesia for elective and emergency caesarean delivery in accordance with our clinical day-to-day operative protocol.
Who may be able to join
- Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Hypothermia During Caesarean Section: Forced-air Warming and 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.
Read the 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.
- Conditions
- Inadvertent Perioperative Hypothermia
- Being tested
- Convective Forced-Air Active Warming
- Keywords
- cesarean section, C-Section, Hypothermia, Spinal Anesthesia, caesarean section, zero heat flux technology, active warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convective Forced-Air Active WarmingProcedure or surgery
Underbody Blanket Model 585 of the 3M BairHugger Series
| Study group | Role | What they receive |
|---|---|---|
| No Warming | Patients in this group were treated according to our institution's old protocol and did not receive any warming intervention during the surgical procedure. | |
| 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 Receives: Procedure: Convective Forced-Air Active Warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through completion of the surgical procedure, an average of 1 hour
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
Measured: Through completion of the postoperative recovery, an average of 2 hours
Secondary outcomes (3)
Delta_Temp
Temp= Temperature. Delta_Temp=The difference between Tmax -Tmin( the maximum and the minimum recorded temperatures)
Measured: Through completion of the surgical procedure, an average of 1 hour
Delta_Time
The time from the induction of anesthesia to Nadir of temperature values
Measured: Through completion of the surgical procedure, an average of 1 hour
Delta_recovery
The time from Tmin (minimum recorded temperature values) to the recovery of 30% of the dropped body core temperature in degrees Celsius.
Measured: Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start15 Oct 2019
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadvertent Perioperative HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Marien-Hospital Düren
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University
- Responsible party
- Principal investigator, Laurentiu Marin, MD, St. Marien-Hospital Düren
- Investigators
- Laurentiu Marin, MD, Principal investigator, Anaesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132154
- Sponsor's protocol ID
- SMHDN012019
- Status last verified
- May 2021
- First submitted
- 15 Oct 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Hypothermia During Caesarean Section: Forced-air Warming and Continuous Core Temperature Monitoring With Zero-heat-flux
- ClinicalTrials.gov ID
- NCT04132154
- Acronym / sponsor ID
- SMHDN012019
- Conditions
- Inadvertent Perioperative Hypothermia
- Keywords
- cesarean section, C-Section, Hypothermia, Spinal Anesthesia, caesarean section, zero heat flux technology, active warming
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- St. Marien-Hospital DürenUniversity, hospital or other
- Collaborators
- RWTH Aachen University
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Warming | – | –Patients in this group were treated according to our institution's old protocol and did not receive any warming intervention during the surgical procedure. |
| Active Warming | – | Procedure: Convective Forced-Air Active WarmingThis 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Included will be patients undergoing spinal anaesthesia for elective and emergency caesarean delivery in accordance with our clinical day-to-day operative protocol.
Key inclusion criteria (1 listed)
- Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convective Forced-Air Active WarmingUnderbody Blanket Model 585 of the 3M BairHugger Series | Procedure or surgery | Active Warming |
Primary outcome
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).
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
3 secondary outcomes
Delta_Temp
Time frame: Through completion of the surgical procedure, an average of 1 hour
Delta_Time
Time frame: Through completion of the surgical procedure, an average of 1 hour
Delta_recovery
Time frame: Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No. no IPD sharing
Related trials for Inadvertent Perioperative Hypothermia
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingObservational study
The Clinical Decision-Making Skills of Operating Room Nurses Regarding Knowledge of Inadvertent Perioperative Hypothermia
THE EFFECT OF KNOWLEDGE LEVELS OF INADVERTET PERIOPERATIVE HYPOTHERMIA ON CLINICAL DECISION-MAKING SKILLS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurentiu Marin, MD principal investigator
Anaesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inadvertent Perioperative Hypothermia, run by St. Marien-Hospital Düren at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothermia rate OR (time frame: Through completion of the surgical procedure, an average of 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.