Forced air warming to maintain normoTHERMIa during SEDation in the cardiac catheterization laboratory: protocol for the THERMISED pilot randomized controlled trial

Aim: To determine whether applying forced air warming attenuates the impact of sedation-induced impairment of thermoregulation on body temperature of patients who are sedated during interventional procedures in the cardiac catheterization laboratory. Background: A moderate proportion of sedated patients who undergo procedures in the cardiac catheterization laboratory with only passive warming become hypothermic. Hypothermia in the surgical population is associated with increased risk of adverse cardiac events, infections, thrombotic and haemorrhagic complications and prolonged hospital stay. For this reason, investigation of the clinical benefits of preventing hypothermia in sedated patients using active warming is required. Design: Randomized controlled trial. Methods: A total of 140 participants undergoing elective interventional procedures with sedation in a cardiac catheterization laboratory will be recruited from two hospitals in Australia. Participants will be randomized to receive forced air warming (active warming) or usual care (passive warming with heated cotton blankets) throughout procedures. The primary outcome is hypothermia (defined as temperature less than 36°C) at the conclusion of the procedure. Secondary outcomes are postprocedure temperature, postprocedural shivering, thermal discomfort, major complications, disability-free survival to 30 days postprocedure, cost-effectiveness and feasibility of conducting a larger clinical trial. Discussion: The results from this study will provide high-level evidence for practice in an area where there is currently no guidance. Findings will be easily translatable into clinical practice because most hospitals already have forced air warming equipment available for use during general anaesthesia.