Active Warming During Elective Caesearean Section
Primary Purpose
Preoperative Hypothermia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Forced air warming
Conduction warming mattress
Sponsored by
About this trial
This is an interventional prevention trial for Preoperative Hypothermia focused on measuring caesarean section, perioperative hypothermia, active warming, forced air warming, conduction mattress warming, thermal comfort, Prevention of
Eligibility Criteria
Inclusion Criteria:
- Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean section under spinal anaesthesia, where surgery and anaesthesia are expected to be uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part of the caesarean section may also be included.
Exclusion Criteria:
- Age under 18
- BMI <19 or >30
- Diseases of pregnancy: e.g. pregnancy induced hypertension
- Grand Multiparity - ie parity of 5 or greater
- Pre-operative pyrexia (temperature of 37.5 degrees C or greater)
- Pre-operative hypothermia (temperature 36.0 degrees or cooler)
- Significant co-existing maternal disease - e.g. congenital heart disease
- Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid
- Coagulation abnormalities or anticipated excessive blood loss including any form of abnormal placentation
- Surgical procedure expected not to be routine/deviation from normal practice
- Condition preventing full, informed consent.
Sites / Locations
- Sheffield Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Normal care
Forced air warming
Conduction warming mattress
Arm Description
Normal care - no active warming
Underbody forced air warming blanket
Underbody conduction warming mattress
Outcomes
Primary Outcome Measures
Mean temperature on arrival in recovery
The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups.
Secondary Outcome Measures
Peri-operative hypothermia
To find whether these active warming devices significantly reduce the incidence of peri-operative hypothermia during spinal anaesthesia for caesarean section
Full Information
NCT ID
NCT02201095
First Posted
July 15, 2014
Last Updated
October 12, 2016
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02201095
Brief Title
Active Warming During Elective Caesearean Section
Official Title
Active Warming for Elective Caesarean Section - a RCT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
During anaesthesia for caesarean section it is common to lose heat and become hypothermic, (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid and insulated from cold surfaces. There are also 2 types of machine available to actively warm women;
Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air pockets that have warm air blown into them continuously by a fan.
Conduction Warming Mattress - a thin mattress which covers the operating table and the woman lies on top. The padded mattress has strips of material that heat up when electricity passes through it, similar to a normal electric blanket.
We plan to carry out a randomised controlled trial to compare these 2 methods with the current practice of no active warming.
The hypothesis for this study is that active warming women during elective caesarean section prevents women's temperature from dropping and keeps them more comfortable than if active warming were not used.
Detailed Description
When a baby is delivered by a surgical procedure (a caesarean section) the woman will usually have a "spinal" anaesthetic. With a "spinal", local anaesthetic is injected into the spinal fluid to make the woman numb from her chest to her feet, allowing her to be comfortable but awake during the birth. During this type of anaesthetic it is common to lose heat and become cold or "hypothermic" measured as less than 36 degrees Celsius. Becoming this cold can be uncomfortable for the woman but also causes other problems. It can make blood clotting less effective, alter the way wounds heal afterwards and make the woman more likely to develop infections or problems related to her heart and lungs.
To help keep their temperature stable, the investigators give all women fluid into the veins that is already warm and ensure that they are well insulated from any cold surfaces. There are two machines that the investigators can also use to actively warm patients but these are not yet used in every case. The first method is called "Forced Air Warming" and uses a special disposable sheet the woman lies upon with lots of air pockets that have warm air blown into them continuously by a fan. The woman is surrounded by these pockets of warm air, which help to warm her and also insulate against heat loss. The second method is called a "Conduction Warming Mattress" and uses a thin mattress which covers the operating table and the woman lies on top. The padded mattress has strips of material that heat up when electricity passes through it, similar to a normal electric blanket.
The investigators have already looked at the records of some women having caesarean sections in our hospital and found that both forced air warming and conduction mattress warming seem to help them stay warm. However, the investigators would like to study this in more detail and prove scientifically whether these methods are effective. Our aim in this study is to see if warming machines can help prevent women getting too cold, and prove scientifically whether one is more effective.
The hypothesis for this study is that active warming women during elective caesarean section prevents women's temperature from dropping and keeps them more comfortable than if active warming were not used.
The women will have exactly the same anaesthetic as they would have had if they were not in the study. If a woman agrees to be in the study she will be chosen randomly to receive either, normal care (including warmed fluids but no warming machines), additional warming with forced air or additional warming by conduction mattress. Her temperature will be measured at regular intervals before, during and after the caesarean section, at the same time she will be asked to score herself on a thermal comfort scale. The results will be analysed to compare the temperature changes in each group.
The investigators hope that the active warming machines will keep body temperature stable and prevent hypothermia. If the investigators find out that these machines prevent women getting cold, they can ensure that the most effective methods of warming during caesarean section operations are used and minimise problems due to becoming cold.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Hypothermia
Keywords
caesarean section, perioperative hypothermia, active warming, forced air warming, conduction mattress warming, thermal comfort, Prevention of
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal care
Arm Type
No Intervention
Arm Description
Normal care - no active warming
Arm Title
Forced air warming
Arm Type
Active Comparator
Arm Description
Underbody forced air warming blanket
Arm Title
Conduction warming mattress
Arm Type
Active Comparator
Arm Description
Underbody conduction warming mattress
Intervention Type
Device
Intervention Name(s)
Forced air warming
Other Intervention Name(s)
Underbody bairhugger
Intervention Type
Device
Intervention Name(s)
Conduction warming mattress
Other Intervention Name(s)
Inditherm conduction mattress
Primary Outcome Measure Information:
Title
Mean temperature on arrival in recovery
Description
The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups.
Time Frame
Temperature will be measured on arrival in recovery.
Secondary Outcome Measure Information:
Title
Peri-operative hypothermia
Description
To find whether these active warming devices significantly reduce the incidence of peri-operative hypothermia during spinal anaesthesia for caesarean section
Time Frame
Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period.
Other Pre-specified Outcome Measures:
Title
Thermal comfort scores
Description
To assess whether active warming makes patients too hot and assess maternal thermal comfort and satisfaction during active warming.
Time Frame
Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean section under spinal anaesthesia, where surgery and anaesthesia are expected to be uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part of the caesarean section may also be included.
Exclusion Criteria:
Age under 18
BMI <19 or >30
Diseases of pregnancy: e.g. pregnancy induced hypertension
Grand Multiparity - ie parity of 5 or greater
Pre-operative pyrexia (temperature of 37.5 degrees C or greater)
Pre-operative hypothermia (temperature 36.0 degrees or cooler)
Significant co-existing maternal disease - e.g. congenital heart disease
Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid
Coagulation abnormalities or anticipated excessive blood loss including any form of abnormal placentation
Surgical procedure expected not to be routine/deviation from normal practice
Condition preventing full, informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie J Woolnough, Mb ChB
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
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Active Warming During Elective Caesearean Section
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