Domain Lead Investigators
Domain Description
| Objective | The primary objective of the WAVEFORM domain is to determine how abnormal patient‑ventilator interactions (PVIs) affect short‑ and long‑term clinical outcomes in patients with acute hypoxemic respiratory failure (AHRF) receiving mechanical ventilation. Secondary objectives are to: 1. Assess how sedatives, opioids, and neuromuscular blockers—when administered around the time of abnormal PVIs—influence clinical outcomes. 2. Examine whether abnormal PVIs contribute to heterogeneity of treatment effects across different ventilation and sedation strategies. 3. Compare the incidence of abnormal PVIs between various ventilation and sedation approaches. 4. Create a digital repository (biobank) of respiratory waveforms (e.g., airway pressure and flow) collected directly from standard clinical ventilators. |
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| Population | The WAVEFORM study is a prospective, multi centre observational cohort embedded as a domain within the PRACTICAL platform trial. This domain will enroll patients from the platform defined states, including: • Intubated patients not receiving extracorporeal life support (ECLS) with low normalized respiratory system elastance (< 2.5 cm H₂O/mL/kg predicted body weight). • Intubated patients not receiving ECLS with high normalized respiratory system elastance (≥ 2.5 cm H₂O/mL/kg predicted body weight). • Patients receiving extracorporeal life support. |
| Primary Endpoint | Duration of mechanical ventilation (MV) (considering death as a competing event). |
| Design | The WAVEFORM study is a prospective, multi‑centre observational cohort study designed to evaluate how abnormal patient‑ventilator interactions (PVIs) influence short‑ and long‑term clinical outcomes in patients with acute hypoxemic respiratory failure (AHRF) receiving mechanical ventilation. |