Table 4.
Definitions of specific adverse events and serious adverse events to be collected
| Event | Definition |
|---|---|
| Adverse event | |
| Pneumonia | The presence of increased or purulent tracheal secretions, new or progressive radiographic infiltrate and a decreased Pao2/Fio2 ratio (< 240 mmHg or < 32 kPa) |
| Sepsis and septic shock | According to the third international consensus definitions for sepsis and septic shock41 |
| Bradycardia | Requiring pacing |
| Moderate or severe bleeding | According to the GUSTO criteria42 |
| Cooling device-related skin complications | Blistering or skin necrosis in areas covered by surface device |
| Arrythmia | Resulting in haemodynamic compromise (eg, ventricular fibrillation and ventricular tachycardia) |
| Serious adverse event | |
| Arrythmia | Arrythmia necessitating normocapnia |
| Intracranial hypertension | Suspected or confirmed raised intracranial hypertension necessitating normocapnia |
| Seizures | Suspected or confirmed seizures necessitating normocapnia |
Fio2 = fraction of inspired oxygen. GUSTO = Global Use of Strategies to Open Occluded Coronary Arteries. Pao2 = arterial oxygen tension.