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

Primary Purpose

Postoperative Hypothermia

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Hypothermia focused on measuring Postoperative hypothermia, caesarean section, IV fluids warming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital, Port-Royal Maternity

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

The control group

The warming group

Arm Description

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

"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.

Outcomes

Primary Outcome Measures

Incidence of Maternal postoperative hypothermia
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

Secondary Outcome Measures

Maternal Shivering
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
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
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
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
use of a air forced warming blanked, peroperatively and Until H2 after surgery
Neonatal core hypothermia
Measure of Temperature °C with cutaneous thermometer
Apgar score
Clinically evaluated
Apgar score
Clinically evaluated
Apgar score
Clinically evaluated :assessment of the newborn infant well-being
Arterial umbilical pH measurement (physiological parameter)
Blood test
Arterial umbilical base deficit measurement
Blood test
Variation in perioperative hemoglobinemia
Blood test
Hemoglobin concentration
blood test
Postpartum anemia
Maternal hemoglobin concentration
Maternal postoperative recovery
6-minute walk test (6 MWT)
Estimation of Quality of life
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

Full Information

First Posted
April 5, 2018
Last Updated
March 21, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03581721
Brief Title
Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming
Acronym
CESAR-RESOL2
Official Title
Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active IV Fluid Warming: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hypothermia
Keywords
Postoperative hypothermia, caesarean section, IV fluids warming

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
No Intervention
Arm Description
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
Arm Title
The warming group
Arm Type
Experimental
Arm Description
"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 Type
Device
Intervention Name(s)
enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Maternal postoperative hypothermia
Description
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
Time Frame
until Hour 12
Secondary Outcome Measure Information:
Title
Maternal Shivering
Description
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
Time Frame
Until Hour 12
Title
Maternal shivering
Description
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
Time Frame
Until Hour 12
Title
Maternal Thermal discomfort
Description
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
Time Frame
until Hour 12
Title
Maternal Thermal discomfort
Description
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
Time Frame
Until Hour 12
Title
Need of active maternal warming
Description
use of a air forced warming blanked, peroperatively and Until H2 after surgery
Time Frame
Until Hour 12
Title
Neonatal core hypothermia
Description
Measure of Temperature °C with cutaneous thermometer
Time Frame
Within 30th minutes of life
Title
Apgar score
Description
Clinically evaluated
Time Frame
minute 1 after birth
Title
Apgar score
Description
Clinically evaluated
Time Frame
minute 5 after birth
Title
Apgar score
Description
Clinically evaluated :assessment of the newborn infant well-being
Time Frame
minute 10 after birth
Title
Arterial umbilical pH measurement (physiological parameter)
Description
Blood test
Time Frame
Within 30th minutes of life
Title
Arterial umbilical base deficit measurement
Description
Blood test
Time Frame
Within 30th minutes of life
Title
Variation in perioperative hemoglobinemia
Description
Blood test
Time Frame
Within 24hours before cesarean and one day after surgery
Title
Hemoglobin concentration
Description
blood test
Time Frame
one day after surgery
Title
Postpartum anemia
Description
Maternal hemoglobin concentration
Time Frame
One day after surgery
Title
Maternal postoperative recovery
Description
6-minute walk test (6 MWT)
Time Frame
between day 3 and day 5 after surgery
Title
Estimation of Quality of life
Description
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Time Frame
at the time of the postoperative appointment, around 40 days after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Pierre Bonnet, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Alfonsi
Organizational Affiliation
Saint Joseph Hospital, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital, Port-Royal Maternity
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11506130
Citation
Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.
Results Reference
background
PubMed Identifier
27314693
Citation
Perlman J, Kjaer K. Neonatal and Maternal Temperature Regulation During and After Delivery. Anesth Analg. 2016 Jul;123(1):168-72. doi: 10.1213/ANE.0000000000001256.
Results Reference
background
PubMed Identifier
17959975
Citation
Butwick AJ, Lipman SS, Carvalho B. Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia. Anesth Analg. 2007 Nov;105(5):1413-9, table of contents. doi: 10.1213/01.ane.0000286167.96410.27.
Results Reference
background
PubMed Identifier
24681658
Citation
Horn EP, Bein B, Steinfath M, Ramaker K, Buchloh B, Hocker J. The incidence and prevention of hypothermia in newborn bonding after cesarean delivery: a randomized controlled trial. Anesth Analg. 2014 May;118(5):997-1002. doi: 10.1213/ANE.0000000000000160.
Results Reference
background
PubMed Identifier
19502035
Citation
Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.
Results Reference
background
PubMed Identifier
26385660
Citation
Sultan P, Habib AS, Cho Y, Carvalho B. The Effect of patient warming during Caesarean delivery on maternal and neonatal outcomes: a meta-analysis. Br J Anaesth. 2015 Oct;115(4):500-10. doi: 10.1093/bja/aev325.
Results Reference
background
PubMed Identifier
26895002
Citation
Cobb B, Cho Y, Hilton G, Ting V, Carvalho B. Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. Anesth Analg. 2016 May;122(5):1490-7. doi: 10.1213/ANE.0000000000001181.
Results Reference
background

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Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming

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