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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Antonella Cotoia, MD contact

+393297174175

antonella.cotoia@unifg.it

Gilda Cinnella, MD contact

gilda.cinnella@unifg.it

Italy1 site, 1 recruiting
  • Ospedali Riuniti

    Foggia, Apulia, 71100

    Antonella Cotoia, MD, +39 3297174175, antonella.cotoia@unifg.it

    Gilda Cinnella, MD, gilda.cinnella@unifg.it

    Recruiting

Other trials in Italy

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.

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 groups in NCT03473470
Study groupRoleWhat they receive
not warmedNo interventionNot warming system
warmed group 1Active comparatorforced air warming and warmed intravenous fluids
Receives: Device: forced air warming and warmed intravenous fluids
warmed group 2Active comparatorwarmed intravenous fluids
Receives: Device: warmed intravenous fluids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. Neonatal body temperature (T°C)

    with axillary thermometer

    Measured: From neonatal birth until five minutes after the birth

  3. Neonatal Apgar score

    Measurement of Apgar score

    Measured: From neonatal birth and until five minutes after the birth

  4. Incidence of maternal coagulative disorders

    Thromboelastography

    Measured: From the date of randomization until the end of surgery, up to four hours of surgery

  5. 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.

  1. First posted22 Mar 2018
  2. Study start22 Dec 2016
  3. Primary completion1 Sep 2020
  4. Study completion30 Nov 2020 (estimated)

Resources

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)
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

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.

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