Inspiratory Muscle Training in Patients Receiving Ongoing Mechanical Ventilation | Events

Domain Lead Investigators

Objective	To evaluate the feasibility of a full-scale randomized clinical trial (RCT) of inspiratory muscle training (IMT) during and after mechanical ventilation in patients with acute hypoxemic respiratory failure (AHRF).
Population	The trial will enroll patients receiving invasive mechanical ventilation for acute hypoxemic respiratory failure as defined in the PRACTICAL platform-defined states: • Intubated patients, not on extracorporeal life support, with low normalized respiratory system elastance (<2.5 cm H2O/(ml/kg predicted body weight)); • Intubated patients, not on extracorporeal life support, with high normalized respiratory system elastance (≥2.5 cm H2O/(ml/kg predicted body weight)); • Patients on extracorporeal life support. o Note: Only intubated extracorporeal support patients can be considered for this domain.
Primary Endpoint	1. Randomization rate 2. Protocol adherence 3. Loss to follow up
Design	Multi-centre, open-label, pilot RCT (IMPROV trial). Participants will be randomized to receive either IMT using a threshold loading device or usual care, initiated during the readiness-to-wean phase and continued until hospital discharge.

Name	Usual Care
Description	Patients will be treated according to usual care. Use of any IMT in the control group is permitted only if it is part of standard of care at the participating site ICU.
Target sample size	60 adult patients receiving invasive mechanical ventilation for AHRF.
Participating sites	4 Canadian ICUs