DRIVE

DRIVing PrEssure Limited Ventilation in Hypoxemic Respiratory Failure – a Randomised Control Trial

Aim:

To determine the effect of a driving pressure-limited ventilation strategy in comparison to conventional tidal volume limited ventilation in patients receiving invasive mechanical ventilation for acute hypoxemic respiratory failure.

Rationale:

Acute hypoxemic respiratory failure (AHRF) is a common, life-threatening condition associated with substantial morbidity and mortality. Patients with AHRF are vulnerable to nosocomial complications of critical care, and lung and diaphragm injury associated with mechanical ventilation. While substantial progress has been made to reduce these risks and improve outcomes, many aspects of care for patients with AHRF remain untested and poorly defined.

Driving pressure, the elastic pressure generated by inflating the respiratory system with the Vt, reflects the stress applied to the lung. Driving pressure remains high in many patients even when Vt is in the protective range, especially in those with high respiratory system elastance.

A new non-invasive technique allows us to easily detect high driving pressure due to patient breathing effort. A simple ventilator-based technique (expiratory occlusion pressure, Pocc) can measure the patient’s respiratory effort and this information can be used to compute the lung-distending pressure (dynamic transpulmonary driving pressure). Pocc can be measured at regular intervals to ensure that dynamic transpulmonary driving pressure is maintained within safe limits when patients are spontaneously breathing.

In summary, emerging evidence suggests that a driving pressure-limited ventilation strategy is likely superior to current practice. It may reduce mortality in patients with high respiratory system elastance and may accelerate liberation from mechanical ventilation in patients with low respiratory system elastance. The development of the Pocc technique enables detection and prevention of potential lung injury from excess patient breathing effort. The benefit of this approach will be tested in DRIVE RCT.

Study Progress:

The study has been reviewed and approved by the Nepean Blue Mountains Local Health District Human Research Ethics Committee (2023/ETH01996). Recruitment commenced in September 2024. Sample size is not fixed for this Bayesian adaptive RCT.

Funding:

The DRIVE RCT is funded by an NHMRC Medical Research Future Fund (MRFF) Clinical Trials Activity grant (MFR2030653).

Further information:

The DRIVE RCT in Australia is contributing to the Global DRIVE Trial. The DRIVE Trial is operationalised in the Invasive Mechanical Ventilation Domain of the PRACTICAL Platform Trial (www.practicalplatform.org).

Trial Registration: ClinicalTrials.gov Identifier: NCT05440851

Endorsement: This study is endorsed by the Canadian Critical Care Trials Group and is supported by the Australian and New Zealand Intensive Care Society Clinical Trials Group.

Contacts: For further information about this study, please contact the ANZIC-RC DRIVE RCT Project Manager, Rebecca Morgan by email; rebecca.morgan@monash.edu.