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 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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Warming with warming mattress
Brighton and Sussex University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01054209
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Increase in the temperature of the atmosphere near the Earth's surface and in the troposphere, which can contribute to changes in global climate patterns.
The effect of GLOBAL WARMING and the resulting increase in world temperatures. The predicted health effects of such long-term climatic change include increased incidence of respiratory, water-borne, and vector-borne diseases.
Unctuous combustible substances that are liquid or easily liquefiable on warming, and are soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. Depending on their behavior on heating, they are volatile or fixed. (Dorland, 28th ed)
The scroll-like bony plates with curved margins on the lateral wall of the NASAL CAVITY. Turbinates, also called nasal concha, increase the surface area of nasal cavity thus providing a mechanism for rapid warming and humidification of air as it passes to the lung.
Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.
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