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Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming (CESAR-RESOL2)

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ClinicalTrials.gov Identifier: NCT03581721
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE July 19, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
Incidence of Maternal postoperative hypothermia [ Time Frame: until Hour 12 ]
Obtained by placing a skin sensor on the right temporal region and measured using the 3M™ SpotOn™ Monitoring System on arrival at the PACU Hypothermia is defined as a Temperature <36°C
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • Maternal Shivering [ Time Frame: Until Hour 12 ]
    Measured on a 4 points scale (0 = no chills, 1 = intermittent, low intensity, 2 = moderate, 3 = continuous) Just before the spinal anesthesia and every 10 minutes in the operative room
  • Maternal shivering [ Time Frame: Until Hour 12 ]
    Score of 4 points (0 = no chills, 1 = intermittent, low intensity, 2 = moderate, 3 = continuous and intense) On arrival at SSPI, one hour and 2 hours after, and just before leaving the PACU
  • Maternal Thermal discomfort [ Time Frame: until Hour 12 ]
    Visual analogic scale between 0 and 100 (0: absence of thermal discomfort, 100: extreme thermal discomfort) Just before the spinal anesthesia and every 10 min during the surgery
  • Maternal Thermal discomfort [ Time Frame: Until Hour 12 ]
    Numerical scale between 0 and 100 (0: absence of thermal discomfort, 100: extreme thermal discomfort) On arrival at SSP, one hour and 2 hours after, and just before leaving the PACU
  • Need of active maternal warming [ Time Frame: Until Hour 12 ]
    use of a air forced warming blanked, peroperatively and Until H2 after surgery
  • Neonatal core hypothermia [ Time Frame: Within 30th minutes of life ]
    Measure of Temperature °C with cutaneous thermometer
  • Apgar score [ Time Frame: minute 1 after birth ]
    Clinically evaluated
  • Apgar score [ Time Frame: minute 5 after birth ]
    Clinically evaluated
  • Apgar score [ Time Frame: minute 10 after birth ]
    Clinically evaluated :assessment of the newborn infant well-being
  • Arterial umbilical pH measurement (physiological parameter) [ Time Frame: Within 30th minutes of life ]
    Blood test
  • Arterial umbilical base deficit measurement [ Time Frame: Within 30th minutes of life ]
    Blood test
  • Variation in perioperative hemoglobinemia [ Time Frame: Within 24hours before cesarean and one day after surgery ]
    Blood test
  • Hemoglobin concentration [ Time Frame: one day after surgery ]
    blood test
  • Postpartum anemia [ Time Frame: One day after surgery ]
    Maternal hemoglobin concentration
  • Maternal postoperative recovery [ Time Frame: between day 3 and day 5 after surgery ]
    6-minute walk test (6 MWT)
  • Estimation of Quality of life [ Time Frame: at the time of the postoperative appointment, around 40 days after surgery ]
    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming
Official Title  ICMJE Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active IV Fluid Warming: a Randomized Controlled Trial
Brief Summary Maternal hypothermia is very frequent after caesarean delivery under spinal anaesthesia and should be prevented, as it induces discomfort and increases the risk of postoperative complications. Several modalities of active warming have been explored, with contrasting results. Small IV Fluid warming systems offer effective and safe IV fluid warming without discomfort, and are very easy to use. The investigators hypothesize that such devices can efficiently prevent hypothermia after caesarean section even with high flow rates of infusion. The purpose of this study is to determine whether active fluid warming reduces the occurrence of maternal hypothermia after scheduled caesarean section, as compared with no active warming. The investigators plane to conduce a double-blinded randomized controlled trial. Seventy women undergoing scheduled caesarean section under spinal anaesthesia in 3 different maternity units will be included. The primary outcome is the occurrence of maternal hypothermia (<36.0°C) on admission to the post anaesthesia care unit. The secondary outcomes are perioperative maternal hypothermia, maternal thermal discomfort, maternal recovery and neonatal well-being
Detailed Description

Hypothermia is a well-known complication of general and neuraxial anaesthesia. After a caesarean section under spinal anaesthesia, 30 to 40% of the mothers have a core temperature <36°C. Perioperative hypothermia induces maternal thermal discomfort and shivering, but also increases the amount of blood loss and the risks of postoperative wound infections and cardiac complications. In addition, maternal hypothermia may also have an impact on neonatal outcomes. Prevention of maternal hypothermia in women scheduled for caesarean delivery is consequently necessary, and is an important part of enhanced recovery after surgery. Active warming is efficient in preventing postoperative hypothermia. Forced-air warming is the most commonly used modality of active warming. However forced-air warming should be applied for at least 60 minutes to be efficient. As surgical duration for a caesarean is lower than one hour, this technic does not appear really appropriate in this context. In addition, upper body forced-air warming is uncomfortable for women and can interfere with bonding. Consequently forced-air warming is not generally used during caesarean delivery. Warmed IV fluid is another option to prevent perioperative hypothermia, but with contrasting results, depending mainly on the device and on the amount of perioperative fluids infusion. Co-loading IV fluid is recommended to prevent maternal hypotension induced by spinal anaesthesia in the context of caesarean delivery. Small released fluid warmings routinely used in scheduled surgery, are able to warm IV fluid administered with high flows, such as in co-loading IV fluid. But the efficiency of these devices to prevent maternal hypothermia has never been explored in the context of caesarean section under spinal anaesthesia with co-loading.

The investigators hypothesized that warmed IV fluid administered in co-loading with enFlow® or Fluido®Compact decreases the incidence of postoperative maternal hypothermia after caesarean section under spinal anaesthesia.

The investigators will perform a double blinded randomized controlled trial comparing active IV warming with enFlow® or Fluido®Compact versus placebo.

Indeed at the beginning of the study, the performance of the enFlow device were tested. But in February 2019, a study published in Anaesthesia showed that uncoated aluminium plates in fluid warming systems, such as those used in the enFlow system, yielded potentially harmful concentrations of aluminium when using balanced electrolyte solutions (ref Perl Anaesthesia 2019). Consequently this device was quarantined unless there are no alternative fluid warmers available Of note no adverse event has been reported associated with the use of enFlow® device. Consequently, we choose to continue our study with the Fluido®Compact, which is a very similar small fluid warmer but with coated aluminium plate.

After obtaining written informed consent from the patients, 70 pregnant women ASA status 1 or 2 and scheduled for caesarean delivery will be enrolled and randomized into two groups: active IV fluid warming vs no active warming. Written informed consent will be obtained before randomisation using an Internet based randomisation system. Participants will be randomized just after their arrival in the operative room. The clinicians in charge of the patients, the researcher and the woman will be blinded. In the operative room, a venous cannula will be inserted into the forearm, and an infusion of Ringer's lactate solution fluids will be initiated. An enFlow® or Fluido®Compact device will be placed on the IV for all the patients, but turned on only in the group active warming. The device will be hidden in all the patients. Every patient will have a spinal anaesthesia in sitting position with hyperbaric bupivacaine 10mg, sufentanil 3µg and morphine 100µg. An IV co loading with Ringer-Lactate 1000 ml will be started at the beginning of the spinal administration. All the women will be monitored using heart rate, continuous SpO2, non-invasive arterial blood pressure every 1-minute until the baby is born, and then every 5 minutes. Maternal arterial hypotension will be corrected with ephedrine or phenylephrine as appropriate. All the women will receive carbetocin 100µg just after baby extraction. While in the operative room, all the data will be collected on a standardized data collection sheet. In case of maternal temperature <35°C during surgery, an active warming blanket will be used. The enFlow® or Fluido®Compact device will be taken off at the end of the surgery just before leaving the operative room.

In addition, postoperative data will be collected during the admission to the post-anaesthesia care unit (PACU). In case of maternal temperature <36°C in the PACU, a warming blanket will be used.

The sample size calculation revealed that 62 participants were required to ensure that a 30% decrease in the incidence of postoperative maternal hypothermia will be detected (power = 0.9 ; α= 0,05). The investigators decided to enroll 70 women because of the risks of secondary exclusions and of lost of follow up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Hypothermia
Intervention  ICMJE Device: enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer
The fluid warmer will be set up by an external co-investigator in every patient included in the study. It will be turned on in patients belonging to the "warming" group, and turned off in the control group
Study Arms  ICMJE
  • No Intervention: The control group
    Control group according to usual practices: no active warming (no fluid warming). The fluid warmer device will be set up but not activated. The control group will receive IV fluid coload at room temperature through the fluid warmer set to "off". The device is hidden
  • Experimental: The warming group
    "IV fluid warming with the enFlow® or Fluido®Compact IV fluid warmer" : Women will receive IV fluid coload warmed to 40°C through the enFlow® or Fluido®Compact device. The box will be also hidden. The fluid warmer will be turned off at the end of surgery, just before transfer to the PACU.
    Intervention: Device: enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Pregnant women

  • without any major co-morbidity (ASA status 1 or 2),
  • with normal singleton pregnancy,
  • who will deliver by scheduled caesarean section under spinal anesthesia at gestational age ≥ 37 weeks of amenorrhea,
  • Aged ≥ 18 years
  • with health insurance

Exclusion Criteria:

  • Patient refusal to participate in the study
  • Maternal temperature ≥38.0 ° C or <36.0 ° C at the time of randomization,
  • Spinal anaesthesia refused or contraindicated,
  • unplanned caesarean section
  • caesarean delivery scheduled since less than 48 hours
  • caesarean section performed under epidural or general anesthesia
  • participation of the mother in another interventional research or intervention, or during the exclusion period following a previous search
  • unability to give written consent
  • body mass index> 40kg / m2
  • gravidic hypertensive disease
  • uncontrolled diabetes
  • cardiovascular disease under treatment
  • coagulation disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Pierre Bonnet, Bonnet : +33 1 48 51 39 21 marie-pierre.bonnet@aphp.fr
Contact: Laurence l, PhD +33 1 58 41 35 45 laurence.lecomte@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03581721
Other Study ID Numbers  ICMJE K170402J
2017-A03139-4 ( Registry Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Pierre Bonnet, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Pascal Alfonsi Saint Joseph Hospital, Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP