A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Hypothermia
Intervention
Warming with warming mattress
Location
Brighton and Sussex University Hospitals NHS Trust
Brighton
East Sussex
United Kingdom
BN25BE
Status
Recruiting
Source
Brighton and Sussex University Hospitals NHS Trust
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01054209
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Global Warming
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.
Greenhouse Effect
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.
Oils
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)
Turbinates
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.
Hypothermia, Induced
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.
Clinical Trials
The purpose of this study is to determine whether a custom-made forced-air warming mattress can prevent heat loss in patients undergoing vascular surgery better than a circulating-water ma...
Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet...
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) bab...
Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical)....
The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypoth...
PubMed Articles
Research supports the practice of preprocedure warming as a method to prevent the development of unplanned perioperative hypothermia. ASPAN defines hypothermia as a core temperature lower than 36°C....
Summary We compared the effect of delivering fluid warmed using two methods in 76 adult patients having short duration surgery. All patients received a litre of crystalloid delivered either at room te...
OBJECTIVES: Neonates and infants are at the highest risk of developing perioperative hypothermia. A number of methods to prevent hypothermia during pediatric anesthesia are in use, and despite the fac...
PURPOSE: It has been reported that recently developed circulating-water garments transfer more heat than a forced-air warming system. The authors evaluated the hypothesis that ci...
A meta-analysis of experimental warming effects on terrestrial nitrogen pools and dynamics.
Global warming may have profound effects on terrestrial ecosystems. However, a comprehensive evaluation of the effects of warming on ecosystem nitrogen (N) pools and dynamics is not available. Here, w...
