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A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section

2014-08-27 03:16:27 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:27-0400

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