None listed
Conditions
Brief summary
Hypothermia is a known adverse effect of general and regional anaesthesia. It is associated with increased risk of complications including surgical site infections and bleeding. For this reason, it is recommended that strategies are implemented to prevent hypothermia. The most effective strategy is forced-air warming. Of note, with advances in medical technology continuing to expand the indications for minimally invasive surgical techniques, sedation is likely to be increasingly used for many procedures that once could only be performed with general anaesthesia. Interventions to prevent hypothermia from occurring, such as forced air warming, are not currently used for sedated patients. Yet, we recently observed in one of our previous studies that about one quarter of patients undergoing procedures with sedation were hypothermic after their procedure. Sedated patients who become hypothermic may be at similar risk of developing complications, like infections and bleeding, to those patients who undergo a general or regional anaesthetic. As such, investigation of the clinical benefits of preventing hypothermia in sedated patients is required. This research aims to determine whether forced air warming reduces hypothermia in sedated patients. The results could potentially benefit the large number of patients undergoing interventional procedures with sedation.
Interventions
Participants randomised to the intervention group will receive forced air warming for the duration of the procedure. The WarmTouchTM WT 6000 Warming Unit (Covidien, USA) will be used. The ‘upper body’ blanket attachment will be used for percutaneous coronary interventions and ablation of cardiac arrhythmias. The ‘lower body’ blanket attachment will be used for cardiac rhythm management device implantation procedures. Device temperature will be initially set at 43 degrees C. Participants will be
Participants randomised to the intervention group will receive forced air warming for the duration of the procedure. The WarmTouchTM WT 6000 Warming Unit (Covidien, USA) will be used. The ‘upper body’ blanket attachment will be used for percutaneous coronary interventions and ablation of cardiac arrhythmias. The ‘lower body’ blanket attachment will be used for cardiac rhythm management device implantation procedures. Device temperature will be initially set at 43 degrees C. Participants will be monitored for sweating, flushing and thermal discomfort so that the device temperature can be titrated accordingly. The step-down protocol will be followed if a participant complains of feeling uncomfortable (Appendix A). Temperature will also be monitored at 30 minute intervals using an infrared aural canal thermometer for warming device titration purposes. If temperature rises above 37.5 degrees C, active warming will be ceased. Active warming will be ceased at the end of procedures.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing an interventional procedure for cardiovascular disease in the Cardiac Catheter Theatres at The Wesley Hospital and the Cardiac Catheter Laboratory at St Vincent’s Private Hospital, Sydney that is expected to require sedation and be of more than 30 minutes duration will be included. Interventional procedures include percutaneous coronary interventions, implantation of cardiac rhythm management devices (e.g. permanent pacemaker, implantable cardioverter-defibrillator) and ablation of cardiac arrhythmias.
Exclusion criteria
Patients will be excluded from the study if they: -are less than 18 years of age; -are cognitively impaired (due to inability to provide informed consent); -are unable to understand and speak English (due to inability to provide written informed consent); -are undergoing an emergency procedure (e.g. percutaneous coronary intervention for ST elevation myocardial infarction); -are undergoing a diagnostic procedure (e.g. coronary angiogram, electrophysiology study without ablation); -have a current temperature above 37.5 degrees C; -are scheduled for general anaesthesia.
Outcome results
None listed