Preoperative Hypothermia Clinical Trial
Official title:
Active Warming for Elective Caesarean Section - a RCT
During anaesthesia for caesarean section it is common to lose heat and become hypothermic,
(<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid
and insulated from cold surfaces. There are also 2 types of machine available to actively
warm women;
1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air
pockets that have warm air blown into them continuously by a fan.
2. Conduction Warming Mattress - a thin mattress which covers the operating table and the
woman lies on top. The padded mattress has strips of material that heat up when
electricity passes through it, similar to a normal electric blanket.
We plan to carry out a randomised controlled trial to compare these 2 methods with the
current practice of no active warming.
The hypothesis for this study is that active warming women during elective caesarean section
prevents women's temperature from dropping and keeps them more comfortable than if active
warming were not used.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean section under spinal anaesthesia, where surgery and anaesthesia are expected to be uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part of the caesarean section may also be included. Exclusion Criteria: - Age under 18 - BMI <19 or >30 - Diseases of pregnancy: e.g. pregnancy induced hypertension - Grand Multiparity - ie parity of 5 or greater - Pre-operative pyrexia (temperature of 37.5 degrees C or greater) - Pre-operative hypothermia (temperature 36.0 degrees or cooler) - Significant co-existing maternal disease - e.g. congenital heart disease - Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid - Coagulation abnormalities or anticipated excessive blood loss including any form of abnormal placentation - Surgical procedure expected not to be routine/deviation from normal practice - Condition preventing full, informed consent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Sheffield Teaching Hospitals NHS Trust | Sheffield | South Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Thermal comfort scores | To assess whether active warming makes patients too hot and assess maternal thermal comfort and satisfaction during active warming. | Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours. | No |
| Primary | Mean temperature on arrival in recovery | The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups. | Temperature will be measured on arrival in recovery. | No |
| Secondary | Peri-operative hypothermia | To find whether these active warming devices significantly reduce the incidence of peri-operative hypothermia during spinal anaesthesia for caesarean section | Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period. | No |