Table 1.
Classification of adverse event severity
| Grade of adverse event | Definitions |
|---|---|
| Grade 0 | No adverse event (for coding and analysis purpose, grade allocated to patients with no adverse event) |
| Grade 1 | Isolated drop in SpO2 during BAL with no need of change in respiratory support (no change in oxygen flow rate or in FiO2 or in ventilator settings) |
| Grade 2 | Need of change in respiratory support (excluding intubation) but no clinically significant respiratory event declared, or clinical adverse events that did not lead to changes in therapy, regardless they were judged related or not to the BAL procedure |
| Grade 3 | Clinical adverse events that led to change(s) in therapy, including clinically significant respiratory events that need modification(s) in respiratory support, regardless they were judged related or not to the BAL procedure |
| Grade 4 | Life-threatening conditions (e.g., need of emergent tracheal intubation; shock with need of vasopressor therapy, bradycardia, ventricular arrhythmia, resuscitated cardiac arrest, etc.) |
| Grade 5 | Death within 24 h |
BAL bronchoalveolar lavage, FiO2 inspired fraction of oxygen, SpO2 blood oxygen saturation measured by pulse oximetry