Adaptive Ventilation Strategies + Corticosteroids for Critical Respiratory Insufficiency
(PRACTICAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing new ways to help patients with severe breathing problems. It includes using special machines to remove carbon dioxide from the blood, trying new ventilator methods, and giving steroids early. These treatments aim to improve breathing and reduce lung damage.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently using corticosteroids, you may not be eligible for certain parts of the trial.
Is the treatment generally safe for humans?
Lung-protective ventilation strategies, including ultra-protective ventilation with extracorporeal support, are generally considered safe and have been standard practice for managing severe lung conditions like acute respiratory distress syndrome (ARDS). However, they can be associated with blood-related complications, especially when using devices not designed for low blood-flow rates.12345
How does the treatment 'Adaptive Ventilation Strategies + Corticosteroids for Critical Respiratory Insufficiency' differ from other treatments for this condition?
This treatment is unique because it combines ultra-protective ventilation, which uses lower airway pressures to minimize lung injury, with extracorporeal support to remove carbon dioxide from the blood, potentially benefiting patients with severe respiratory distress. Conventional treatments may not include this combination of strategies, which aims to protect the lungs while managing respiratory acidosis.14678
What data supports the effectiveness of the treatment Adaptive Ventilation Strategies + Corticosteroids for Critical Respiratory Insufficiency?
Research suggests that ultra-lung-protective ventilation, especially when combined with extracorporeal support, may help reduce lung injury in severe respiratory conditions like acute respiratory distress syndrome (ARDS). However, the benefits are mainly seen in very severe cases, and there are risks involved, such as blood-related complications.13568
Who Is on the Research Team?
Ewan Goligher, MD, PhD
Principal Investigator
University Health Network, Toronto
Eddy Fan, MD, PhD
Principal Investigator
University Health Network, Toronto
Niall Ferguson, MD, MSc
Principal Investigator
University Health Network, Toronto
Lorenzo Del Sorbo, MD
Principal Investigator
University Health Network, Toronto
Bram Rochwerg, MD, MSc
Principal Investigator
McMaster University
Bijan Teja, MD
Principal Investigator
Unity Health Toronto
John Muscedere, MD
Principal Investigator
Queens University
Are You a Good Fit for This Trial?
Adults over 18 with acute hypoxemic respiratory failure (AHRF) needing high-flow nasal cannula, non-invasive or invasive ventilation can join. They must have had corticosteroids for AHRF for at least 10 days and not be suffering from conditions like heart failure or pulmonary embolism. Exclusions include allergy to dexamethasone, severe brain injury, certain contraindications to anticoagulation, previous neuromuscular disorders, suspected COVID-19 infection among others.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various interventions for acute hypoxemic respiratory failure, including mechanical ventilation strategies and pharmacological agents
Follow-up
Participants are monitored for safety and effectiveness after treatment, including ventilator-free days and survival status
Open-label extension (optional)
Participants may continue to receive study interventions as part of ongoing evaluation
What Are the Treatments Tested in This Trial?
Interventions
- Conventional lung-protective ventilation
- Ultra-protective ventilation facilitated by extracorporeal support
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ewan Goligher
Lead Sponsor
University Health Network, Toronto
Lead Sponsor