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 aims to test new treatments for acute hypoxemic respiratory failure (AHRF), a serious condition where the lungs can't supply enough oxygen to the blood. Researchers are exploring various breathing support methods, such as conventional lung-protective ventilation and ultra-protective ventilation with extracorporeal support, as well as medications like corticosteroids, to determine their effectiveness in improving patient outcomes. Multiple treatment groups will assess how well each approach addresses different aspects of lung failure. Individuals with recent or worsening breathing problems who require significant oxygen support might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future treatments for AHRF.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that standard lung-protective ventilation is usually well-tolerated by patients with acute breathing problems. Studies indicate it reduces lung damage during mechanical ventilation. However, adherence to this method can vary, potentially affecting its effectiveness.
For ultra-protective ventilation, which uses a machine to help remove carbon dioxide, research highlights its use mainly in severe cases. This approach allows the lungs to rest. Some studies suggest it benefits very sick patients, but risks such as bleeding or infection exist due to its invasive nature.
Both treatments aim to protect the lungs, but each presents its own challenges and risks. Discuss potential side effects and benefits with healthcare providers when considering joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about these ventilation strategies for critical respiratory insufficiency because they explore innovative ways to support patients. Ultra-protective ventilation, coupled with extracorporeal carbon dioxide removal, seeks to minimize lung damage by reducing driving pressure and respiratory rate, which is a novel approach compared to traditional lung-protective strategies. Another intriguing method is the VV ECMO-facilitated strategy, which aims to promote earlier awakening, extubation, and rehabilitation, potentially speeding up recovery. Additionally, the CORT-E2 trial examines the timing and duration of corticosteroid use, which could refine how inflammation is managed in acute hypoxemic respiratory failure. These strategies could transform care by reducing lung injury and improving recovery times.
What evidence suggests that this trial's treatments could be effective for acute hypoxemic respiratory failure?
This trial will compare different adaptive ventilation strategies and corticosteroid treatments for critical respiratory insufficiency. One arm will use ultra-protective ventilation facilitated by extracorporeal carbon dioxide removal (ECCO2R). Research has shown that ECCO2R might help patients with severe breathing problems by allowing doctors to use gentler ventilator settings, which can prevent further lung damage and manage respiratory acidosis. Previous research suggested that this method is safe and could lead to better recovery for patients with serious lung issues.
Another arm will investigate the use of corticosteroids. Studies have shown that starting corticosteroids early and using them for a longer period can reduce lung inflammation, potentially helping patients breathe easier and recover more quickly. However, the best timing and duration for this treatment remain under investigation.678910Who Is on the Research Team?
Laveena Munshi, MD
Principal Investigator
Mount Sinai Hospital, Canada
Dmitry Rozenberg, MD, PhD
Principal Investigator
University Health Network, Toronto
Anastasia Newman, PhD
Principal Investigator
McMaster University
Ewan Goligher, MD, PhD
Principal Investigator
University Health Network, Toronto
Niall Ferguson, MD, MSc
Principal Investigator
University Health Network, Toronto
Eddy Fan, MD, PhD
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