A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section (ObsIPH)
This study will demonstrate whether an electric warming mattress can reduce the number of patients who get cold and shiver after elective cesarean section.
Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative complications and patient discomfort. Immediately post-operatively such discomfort is due to increased pain and shivering. Patients say that their time in the recovery ward is very stressful and this is prolonged if they become cold (hypothermic)or shiver. Subsequently, patients can suffer with increased risk of infections and delayed discharge from hospital.
For patients (and their babies) having Cesarean sections it is important to start breast feeding as soon as possible, but being cold may delay this.
For some types of surgery measures are put in place to stop patients becoming cold and thereby reduce the number of problems. However this is not the case with patients undergoing Cesarean sections because the special blankets through which hot air is blown to keep them warm are inappropriate for mothers giving birth by Cesarean section as it would make it difficult for a mother to have good skin-to-skin contact with her new baby immediately after delivery - an important part in the bonding process.
A solution is to use a new warming mattress. This has been shown to be safe and effective with some types of surgery, but has not been tested in Cesarean sections.
In the investigators study,the investigators will warm a group of patients undergoing planned Cesarean section and compare them to an unwarmed group to see if there is any difference primarily in post-operative temperature. Secondarily, the investigators will also look for differences in total blood loss, incidence of blood transfusion, wound infection, shivering, the immediate health of the baby, time taken to become fit for discharge from recovery, length of hospital stay and time to breast-feeding.
Device: Warming with warming mattress
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section|
- This study intends to investigate whether an electric warming mattress can reduce post-operative hypothermia (defined as body temperature of less than 36.0ºC) in patients undergoing planned Caesarean section. [ Time Frame: On admission to recovery room - time variable, same day as procedure ] [ Designated as safety issue: No ]
- This study intends to investigate whether an electric warming mattress can reduce the incidence of shivering in patients undergoing planned Caesarean section. [ Time Frame: From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure ] [ Designated as safety issue: No ]
- Differences in total blood loss [ Time Frame: At the end of the Caesarean section - time variable ] [ Designated as safety issue: No ]
- Differences in incidence of blood transfusion [ Time Frame: From start of Caesarean section to discharge from hospital - times variable ] [ Designated as safety issue: No ]
- Differences in wound infection rates [ Time Frame: From immediately post-operative till 1 month post procedure ] [ Designated as safety issue: No ]
- Differences in shivering (severity and the need for treatment) [ Time Frame: On admission to recovery room - time variable, same day as procedure ] [ Designated as safety issue: No ]
- Differences in immediate health of baby [ Time Frame: At time of baby's birth - same day as Caesarean section ] [ Designated as safety issue: No ]
- Differences in time taken for mother to become fit for discharge from recovery [ Time Frame: Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure ] [ Designated as safety issue: No ]
- Differences in length of hospital stay [ Time Frame: Worked out reterospectively post-discharge from hospital patient notes ] [ Designated as safety issue: No ]
- Differences in time to breast-feeding (if mother chooses to breast feed) [ Time Frame: From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
No Intervention: A
Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
Active Comparator: B
Warming mattress activated otherwise same management as Arm A.
Device: Warming with warming mattress
Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.
Inditherm Alpha systems, OTM1: 1900mm x 585mm
Other Name: Inditherm Alpha systems, OTM1: 1900mm x 585mm
This project will be a randomised controlled trial comparing a warming mattress with current standard of care (no warming).
Prospective participants will be invited by letter and provided with a information booklet explaining the study and their rights. Informed consent will be taken in writing.
Patients will be randomised using a protocol created by the Trusts Clinical Investigations Research Unit who will use an Internet based randomisation system.
The researcher will not be blinded as it is not logistically feasible. The statistician analysing the results will be blinded to which group receives warming.
Study data will be collected manually on a standardised data collection sheet.
All enrolled patients will have their temperatures measured at specified times and will be observed for shivering. Data collection required to measure the primary outcomes will be complete by time of discharge from the recovery room. Data collection for secondary outcomes will be prospective and retrospective and will occur from time of anaesthesia through to one month after the procedure.
All patients will receive routine post-operative care.
To ensure any late complications are not missed we will interview the patients by phone one month after the date of their procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054209
|Brighton and Sussex University Hospitals NHS Trust|
|Brighton, East Sussex, United Kingdom, BN25BE|
|Study Chair:||Christopher M Harper, MBBS, FRCA||BSUH NHS Trust, UK|
|Principal Investigator:||Abhijoy Chakladar, BSc, MBBS, MRCP, FRCA||BSUH NHS Trust, UK|