Hypothermia; AnesthesiaNCT03473470
Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery
A study testing forced air warming and warmed intravenous fluids and warmed intravenous fluids in people with Hypothermia; Anesthesia, run by University of Foggia at 1 site in Italy.
Trial summary
A prospective randomized study of healthy term parturients undergoing cesarean delivery was designed to assess the impact of the active warming on perioperative and postoperative temperature. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypothermia; Anesthesia
- What is being tested?
- forced air warming and warmed intravenous fluids and warmed intravenous fluids
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteItaly
- Study dates
- 22 Dec 2016to 30 Nov 2020
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Fever;
- Diabetes mellitus;
- BMI> 40Kg/m²;
- Coaugulation disorders;
- Pre-eclampsia and eclampsia;
- Increased risk of intraoperative hemorrhage
Trial locations and contacts
1 site in 1 country.
Gilda Cinnella, MD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedali Riuniti
Foggia, Apulia, 71100
Antonella Cotoia, MD, +39 3297174175, antonella.cotoia@unifg.it
Gilda Cinnella, MD, gilda.cinnella@unifg.it
About this study
Official title: Evaluation of the Active Warming Effects on Maternal and Neonatal Outcomes During Cesarean Delivery
A prospective randomized study of healthy term parturients undergoing cesarean delivery was designed to assess the impact of the active warming on perioperative and postoperative temperature.
The main objective is to evaluate the maternal core temperature in the perioperative and postoperative period during cesarean delivery.
Read more
The secondary objectives are to assess the incidence of maternal hypothermia, the incidence of maternal shivers, the evaluation of maternal thermal comfort, the neonatal temperature at birth, the Apgar score at 1 and 5 minutes, the umbilical pH, the evaluation of coagulative assessment in case of maternal hypothermia trough the use of thromboelastography.
The patients are randomized into three groups: a group of no warmed patients, a second group of Active waming patients with iv fluids and lower body forced air warming and a third group of Active warming patients with only warmed iv fluids.
The inclusion criteria are healthy parturients up to age 18. The exclusion criteria included parturients who develop fever, diabetes mellitus, BMI up to 40kg/ m2, coagulative disorders, pre eclampsia or eclampsia, all the factors that can cause intraoperative bleeding such as placental abruption or antecedent placenta overgrowth ( placenta previa).
Read the detailed description
The doctor's main purposes during the perioperative period are the monitorign and maintenance of normothermia, as well as the haemodynamic, respiratory, metabolic, analgesic control and monitoring.
Mild hypothermia ( core temperature between 36° and 33° C) is common during general, locoregional or blended anaesthesia. A mild hypothermia can cause a cardiovascular, haematological, metaolic and hormonal alterations that can explain an increased mortality and morbidity in hypothermia patients versus normothermia patients.
Thermic decrease is a physiological event during general or locoregional anaesthesia. Particularly spinal and epidural anaesthesia can cause the thermic decrease because of vasodilation below the level of the sensitive and neuroaxial blockade. In this way there is in the patient an increased heat loss trough radiation. The neuroaxial techniques can reduce the sensory connections and the level of vasoconstriction above the level of the sensorial blockade, reducing the patient capacity to maintain the poichilothermia.
The consequences of hypothermia are important because they can influence the intraoperative management causing complications extending the recovering time and the hospitalization.
The environmental temperature is a critical factor for the development of hypothermia , especially in critically patients. In order to avoid the deveopment of hypothermia the environmental temperature must be maintainde between 21° and 24° C and humidity level of 40- 60%.
Maternal hypothermia is common during cesarean delivery and it can exercise influence over neonatal temperature.
When a mother develops hypothermia the newborn can shows hypotheria, umbilical acidosis, low Apgar score at birth.
The recorded data are the demographic data of the patient such as weight, age and height, the vital signs such as heart rate, arterial pressure, SpO2 or EtCO2 during general anaesthesia, BMI, gestational age and parity, type of anaesthesia, doses and type of anaesthetic used, the development of adverse effects such as hypothermia or hypothension, the blood leaks, the environmental temperature on operative theatre, the temperature of fluids iv in the perioperative period, the maternal core temperature at preoperative, during induction of anaesthesia, after 5 minutes initiating anaesthesia, and then every 10 minutes until the end of the cesarean delivery and also at child birth, at the exit of operative theatre. Maternal temperature measurment will be obtained by using a skin sensor Spot On on a temporal region, the neonatal axillary temperature at 1 and5 minutes from birth using a digital thermometer, Apgar score and umbilical cord blood pH, the pain evaluation using a VAS scale ( 0-10), the maternal shivering by the Bedside Shivering Assessment scale, the maternal comfort using a verbal numerical scale ( 0 = as worst immaginable cold 50= as thermoneutral and 100= as insufferably hot), the timing of pain at induction of anaesthesia and then every 10 minutes until the operative room exit.
- Conditions
- Hypothermia; Anesthesia
- Being tested
- forced air warming and warmed intravenous fluids, warmed intravenous fluids
- Keywords
- Maternal and Neonatal Hypothermia, cesarean delivery
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forced air warming and warmed intravenous fluidsDevice
Use of warming system (forced air)
warmed intravenous fluidsDevice
Use of warming system to have warmed intravenous fluids
| Study group | Role | What they receive |
|---|---|---|
| not warmed | No intervention | Not warming system |
| warmed group 1 | Active comparator | forced air warming and warmed intravenous fluids Receives: Device: forced air warming and warmed intravenous fluids |
| warmed group 2 | Active comparator | warmed intravenous fluids Receives: Device: warmed intravenous fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypothermia (body temperature < 36°C)
to assess the incidence of maternal hypothermia during caesarean delivery
Measured: From the date of randomization until the end of surgery, up to four hours of surgery
Secondary outcomes (5)
Incidence of maternal shivering
Use of the Bedside shivering scale (score 0 no shiver, score 1 mild shiver at the neck or thorax, score 2 moderate shiver at the neck, thorax and arms, score 3 severe shiver at the neck, thorax, arms and legs. Score 2 and 3 are the worse outcomes
Measured: From the date of randomization until the end of surgery, up to four hours of surgery
Neonatal body temperature (T°C)
with axillary thermometer
Measured: From neonatal birth until five minutes after the birth
Neonatal Apgar score
Measurement of Apgar score
Measured: From neonatal birth and until five minutes after the birth
Incidence of maternal coagulative disorders
Thromboelastography
Measured: From the date of randomization until the end of surgery, up to four hours of surgery
maternal thermal comfort
Use of a VAS 0-100 scale (100=insufferably hot, 50=thermoneutral and 0=unimaginably cold); 50 thermoneutral is the better outcome cold, 0=thermally neutral, +50=insufferably hot
Measured: From the date of randomization until the end of surgery, up to four hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start22 Dec 2016
- Primary completion1 Sep 2020
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
- Investigators
- Antonella Cotoia, MD, Principal investigator, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473470
- Sponsor's protocol ID
- 76/CE/2017
- Status last verified
- Sep 2020
- First submitted
- 27 Feb 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Active Warming Effects on Maternal and Neonatal Outcomes During Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03473470
- Acronym / sponsor ID
- 76/CE/2017
- Conditions
- Hypothermia; Anesthesia
- Keywords
- Maternal and Neonatal Hypothermia, cesarean delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 22 Mar 2018 (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.
A prospective randomized study of healthy term parturients undergoing cesarean delivery was designed to assess the impact of the active warming on perioperative and postoperative temperature.
The main objective is to evaluate the maternal core temperature in the perioperative and postoperative period during cesarean delivery.
The secondary objectives are to assess the incidence of maternal hypothermia, the incidence of maternal shivers, the evaluation of maternal thermal comfort, the neonatal temperature at birth, the Apgar score at 1 and 5 minutes, the umbilical pH, the evaluation of coagulative assessment in case of maternal hypothermia trough the use of thromboelastography.
The patients are randomized into three groups: a group of no warmed patients, a second group of Active waming patients with iv fluids and lower body forced air warming and a third group of Active warming patients with only warmed iv fluids.
The inclusion criteria are healthy parturients up to age 18. The exclusion criteria included parturients who develop fever, diabetes mellitus, BMI up to 40kg/ m2, coagulative disorders, pre eclampsia or eclampsia, all the factors that can cause intraoperative bleeding such as placental abruption or antecedent placenta overgrowth ( placenta previa).
Detailed description
The doctor's main purposes during the perioperative period are the monitorign and maintenance of normothermia, as well as the haemodynamic, respiratory, metabolic, analgesic control and monitoring.
Mild hypothermia ( core temperature between 36° and 33° C) is common during general, locoregional or blended anaesthesia. A mild hypothermia can cause a cardiovascular, haematological, metaolic and hormonal alterations that can explain an increased mortality and morbidity in hypothermia patients versus normothermia patients.
Thermic decrease is a physiological event during general or locoregional anaesthesia. Particularly spinal and epidural anaesthesia can cause the thermic decrease because of vasodilation below the level of the sensitive and neuroaxial blockade. In this way there is in the patient an increased heat loss trough radiation. The neuroaxial techniques can reduce the sensory connections and the level of vasoconstriction above the level of the sensorial blockade, reducing the patient capacity to maintain the poichilothermia.
The consequences of hypothermia are important because they can influence the intraoperative management causing complications extending the recovering time and the hospitalization.
The environmental temperature is a critical factor for the development of hypothermia , especially in critically patients. In order to avoid the deveopment of hypothermia the environmental temperature must be maintainde between 21° and 24° C and humidity level of 40- 60%.
Maternal hypothermia is common during cesarean delivery and it can exercise influence over neonatal temperature.
When a mother develops hypothermia the newborn can shows hypotheria, umbilical acidosis, low Apgar score at birth.
The recorded data are the demographic data of the patient such as weight, age and height, the vital signs such as heart rate, arterial pressure, SpO2 or EtCO2 during general anaesthesia, BMI, gestational age and parity, type of anaesthesia, doses and type of anaesthetic used, the development of adverse effects such as hypothermia or hypothension, the blood leaks, the environmental temperature on operative theatre, the temperature of fluids iv in the perioperative period, the maternal core temperature at preoperative, during induction of anaesthesia, after 5 minutes initiating anaesthesia, and then every 10 minutes until the end of the cesarean delivery and also at child birth, at the exit of operative theatre. Maternal temperature measurment will be obtained by using a skin sensor Spot On on a temporal region, the neonatal axillary temperature at 1 and5 minutes from birth using a digital thermometer, Apgar score and umbilical cord blood pH, the pain evaluation using a VAS scale ( 0-10), the maternal shivering by the Bedside Shivering Assessment scale, the maternal comfort using a verbal numerical scale ( 0 = as worst immaginable cold 50= as thermoneutral and 100= as insufferably hot), the timing of pain at induction of anaesthesia and then every 10 minutes until the operative room exit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| not warmed | No intervention | –Not warming system |
| warmed group 1 | Active comparator | Device: forced air warming and warmed intravenous fluidsforced air warming and warmed intravenous fluids |
| warmed group 2 | Active comparator | Device: warmed intravenous fluidswarmed intravenous fluids |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Fever;
- Diabetes mellitus;
- BMI> 40Kg/m²;
- Coaugulation disorders;
- Pre-eclampsia and eclampsia;
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 |
|---|---|---|
| forced air warming and warmed intravenous fluidsUse of warming system (forced air) | Device | warmed group 1 |
| warmed intravenous fluidsUse of warming system to have warmed intravenous fluids | Device | warmed group 2 |
Primary outcome
incidence of hypothermia (body temperature < 36°C)
Time frame: From the date of randomization until the end of surgery, up to four hours of surgery
to assess the incidence of maternal hypothermia during caesarean delivery
5 secondary outcomes
Incidence of maternal shivering
Time frame: From the date of randomization until the end of surgery, up to four hours of surgery
Neonatal body temperature (T°C)
Time frame: From neonatal birth until five minutes after the birth
Neonatal Apgar score
Time frame: From neonatal birth and until five minutes after the birth
Incidence of maternal coagulative disorders
Time frame: From the date of randomization until the end of surgery, up to four hours of surgery
maternal thermal comfort
Time frame: From the date of randomization until the end of surgery, up to four hours of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Hypothermia; Anesthesia
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Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
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Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
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.
Gilda Cinnella, MD contact
Antonella Cotoia, MD principal investigator
University of Foggia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forced air warming and warmed intravenous fluids and warmed intravenous fluids in people with Hypothermia; Anesthesia, run by University of Foggia at 1 site in Italy.
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 0 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: status not confirmed, as of the sponsor's last update on 14 Sep 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Cotoia, MD (+393297174175, antonella.cotoia@unifg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypothermia (body temperature < 36°C) (time frame: From the date of randomization until the end of surgery, up to four hours of surgery). 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 14 Sep 2020.