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Trial registered on ANZCTR


Registration number
ACTRN12614001088639
Ethics application status
Approved
Date submitted
25/09/2014
Date registered
10/10/2014
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A preoperative warming regime versus no preoperative warming for maintenance of normothermia in women receiving intrathecal morphine for caesarean section.
Scientific title
Women receiving intrathecal morphine for caesarean section receiving preoperative warming versus no preoperative warming for maintenance of normothermia.
Secondary ID [1] 285401 0
Nil
Universal Trial Number (UTN)
U1111-1162-2246
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadvertent perioperative hypothermia 293147 0
Condition category
Condition code
Anaesthesiology 293411 293411 0 0
Other anaesthesiology
Reproductive Health and Childbirth 293488 293488 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 20 minute period of full body preoperative warming using a Cocoon (Trademark) forced air warming device, whilst the patient is waiting in the preoperative waiting area and immediately before transfer to the operating theatre for induction of spinal anaesthesia.
Forced air warming will be administered via a full body warming blanket applied whilst participants are sitting in a recliner. The temperature setting applied will be 43 degrees celsius.
Intervention code [1] 290318 0
Treatment: Devices
Intervention code [2] 290384 0
Prevention
Comparator / control treatment
Usual care: no forced air prewarming, warmed cotton blankets applied during the preoperative waiting period in the preoperative waiting area (which have been kept in a warming cabinet set at 60 degrees celsius and remain in place throughout surgery).
Control group
Active

Outcomes
Primary outcome [1] 293239 0
Primary outcome: mean maternal core temperature decline ( in degrees celsius) as measured at the following sites: aural canal via infrared thermometer, bladder (via urinary catheter thermistor)

Timepoint [1] 293239 0
Baseline (aural)
Prior to induction of spinal anaesthesia (aural)
Post induction of spinal anaesthesia (aural)
Every 15 minutes throughout the surgical procedure (bladder and aural)
At the end of the surgical procedure (bladder and aural canal)
On post-anaesthetic care unit (PACU) arrival, (aural)
Every 15 minutes until PACU ready for discharge time (aural)
Secondary outcome [1] 310656 0
Maternal hypothermia (core temperature to below 36 degrees celsius) measured by infrared aural canal thermometer and urinary catheter thermistor
Timepoint [1] 310656 0
Prior to induction of spinal anaesthesia
Post induction of spinal anaesthesia
Every 15 minutes during procedure
At the end of the procedure
On arrival to post-anaesthetic care unit
Secondary outcome [2] 310657 0
Maternal thermal comfort via a 100mm visual analogue scale (VAS)
Timepoint [2] 310657 0
Baseline
Prior to induction of spinal anaesthesia
At end of surgical procedure
Secondary outcome [3] 310658 0
Maternal shivering measured on a three-point scale
Timepoint [3] 310658 0
Baseline
Prior to induction of spinal anaesthesia.
Operating theatre:end of procedure
PACU: arrival
PACU: 15 mins
PACU: 30 mins
Secondary outcome [4] 310659 0
Apgar scores
Timepoint [4] 310659 0
1 minute after delivery
5 minutes after delivery
Secondary outcome [5] 310660 0
Neonatal axillary temperature (degrees celsius) via electronic thermometer
Timepoint [5] 310660 0
At birth

Eligibility
Key inclusion criteria
Women receiving intrathecal morphine whilst undergoing spinal anaesthesia for elective caesarean section at the Mater Mother’s hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency caesarean section
Epidural top-up, general anaesthesia or epidural opiates during combined spinal-epidural
Women not receiving intrathecal morphine during spinal anaesthesia for caesarean section
Known allergy to morphine
Admission temperature of > 37 degrees celsius
Known impaired thermoregulation or thyroid disorders
Tympanic membrane/aural canal not visible on otoscopy
Vascular disease or poor cutaneous perfusion
Planned postoperative ICU admissions
American Society of Anesthesiologist’s (ASA) score > II
History of preeclampsia or eclampsia.
Delay between completion of warming intervention and the transfer to theatre that is greater than 20 minutes.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants for recruitment will be identified via the elective surgery booking process and will be approached at the Preoperative Assessment Clinic held at approximately 36 weeks gestation. Written information (Letter of Invitation, Participant Information Brochure) and oral information will be provided by the principal investigator or research assistant. Potential participants will be given the opportunity to ask questions. Informed consent will be obtained prior to randomisation into study groups. Further eligibility for inclusion into the study will be determined on the day of surgery (in relation to inclusion/exclusion criteria related to health status, such as baseline temperature <37 degrees celsius or preeclampsia).
Allocation to treatment or control groups will be concealed from the allocator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to either the control or intervention group by the opening of a sealed envelope after they have consented to take part, on the day of admission. The allocation sequence will be generated via simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 15 participants in each group is required. The calculation was based on a repeated measures design with the initial temperatures being the same and the temperature decline being 0.4 degrees celsius greater in the unwarmed group than the warmed group 45 minutes after commencement of surgery. A standard deviation of 0.4 degrees celsius was used in the calculation, based on the data reported by Chung et al (2012). A type I error rate of 0.05 and a power of 90% were specified. The sample size was inflated from a total of 30 to a total of 50 to allow for attrition.

SPSS software (version 15) will be utilised for data analysis. Descriptive statistics will be used to report the sample characteristics, and summarise hypothermia prevalence. Means standard deviations, median and interquartile ranges, will be reported, along with 95% confidence intervals where appropriate. A p value of <0.05 will be considered statistically significant. Repeated measures Analysis of Variance (ANOVA) will be used for examining core temperature decline within and between groups. Additionally, a random coefficients model will be constructed by fitting curves to individual data and these will be used to examine within-group and between-group variability in more detail. All analyses will be performed on the Intention to Treat population. A Bland-Altman analysis will be used for examining agreement between aural canal and bladder temperature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/01/2015
Actual
4/02/2015
Date of last participant enrolment
Anticipated
Actual
10/02/2016
Date of last data collection
Anticipated
Actual
16/02/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3022 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 8733 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 290008 0
Other Collaborative groups
Name [1] 290008 0
PNAQ
Country [1] 290008 0
Australia
Primary sponsor type
Individual
Name
Judy Munday
Address
Mater Nursing Research Centre, Mater Health Services, Rm 284 Level 2, Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 288692 0
Hospital
Name [1] 288692 0
Mater Nursing Research Centre, Mater Health Services
Address [1] 288692 0
Mater Nursing Research Centre, Mater Health Services, Rm 284 Level 2, Aubigny Place, Raymond Terrace, South Brisbane QLD 4101
Country [1] 288692 0
Australia
Other collaborator category [1] 278162 0
University
Name [1] 278162 0
Queensland University of Technology
Address [1] 278162 0
School of Nursing, Victoria Park Road, Kelvin Grove, QLD 4059
Country [1] 278162 0
Australia
Other collaborator category [2] 278163 0
Individual
Name [2] 278163 0
Dr David Sturgess
Address [2] 278163 0
Dept of Intensive Care Medicine, Mater Health Services, Raymond Terrace, South Brisbane, QLD 4101
Country [2] 278163 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291716 0
Mater Human Research Ethics Committee
Ethics committee address [1] 291716 0
Mater Research, Rm 294, Level 2, Aubigny Place, South Brisbane, QLD 4101
Ethics committee country [1] 291716 0
Australia
Date submitted for ethics approval [1] 291716 0
25/07/2014
Approval date [1] 291716 0
17/09/2014
Ethics approval number [1] 291716 0
HREC/14/MHS/157

Summary
Brief summary
Women undergoing caesarean section experience high rates of heat loss and hypothermia related to surgery and
anaesthesia. As well as causing discomfort, hypothermia experienced during and after anaesthesia and surgery is
also associated with many adverse effects, for example increased blood loss. It is also thought that spinal
morphine, commonly given during caesarean section for pain relief, may also exacerbate heat loss. This project
aims to test warming patients preoperatively via a warming blanket (which utilises heated air) to reduce the amount
of heat loss during surgery.
A randomised controlled study design will be used: the control group will receive normal care while the intervention
group will receive preoperative warming.
Potential participants will be identified via the surgical booking process. Recruitment and informed consent will
occur at the preoperative assessment appointment. Participants will be randomly assigned, on the day of surgery, to either the control group receiving usual care, or the intervention group receiving preoperative warming.
Temperature will be recorded throughout the preoperative period, during surgery and during the postoperative
period in the recovery unit. Data will be analysed to investigate differences in the amount of temperature lost
(temperature decline) in each group and comparisons made. Thermal comfort experienced by mothers will also be
determined, as well as the incidence of shivering. Comparisons will also be made between newborn temperature and Apgar scores (used to assess the health of the newborn).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51698 0
Dr Judy Munday
Address 51698 0
Rm 529, N Block, School of Nursing, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD 4059
Country 51698 0
Australia
Phone 51698 0
+61 7 3138 8209
Fax 51698 0
+61 7 3138 3814
Email 51698 0
[email protected]
Contact person for public queries
Name 51699 0
Judy Munday
Address 51699 0
Rm 529, N Block, School of Nursing, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD 4059
Country 51699 0
Australia
Phone 51699 0
+61 7 3138 8209
Fax 51699 0
+61 7 3138 3814
Email 51699 0
[email protected]
Contact person for scientific queries
Name 51700 0
Judy Munday
Address 51700 0
Rm 529, N Block, School of Nursing, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD 4059
Country 51700 0
Australia
Phone 51700 0
+61 7 3138 8209
Fax 51700 0
+61 7 3138 3814
Email 51700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is aggregated only.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Munday, J., Osborne, S., Yates, P., Sturgess, D., ... [More Details]

Documents added automatically
No additional documents have been identified.