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Adaptive Ventilation Strategies + Corticosteroids for Critical Respiratory Insufficiency (PRACTICAL Trial)
N/A
Recruiting
Led By Lorenzo Del Sorbo, MD
Research Sponsored by Ewan Goligher
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have already received 10 days of corticosteroid specifically for acute respiratory failure
Ongoing AHRF requiring HFNC, NIV, or invasive ventilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
PRACTICAL Trial Summary
This trial evaluates novel interventions for people with AHRF to find the best approach to invasive mechanical ventilation and the role of corticosteroids for patients with persistent AHRF.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing various interventions: usual care without extended corticosteroids; different mechanical ventilation strategies such as ultra-protective ventilation facilitated by ECMO and driving pressure-limited ventilation; early versus extended doses of corticosteroids in patients with persistent AHRF.See study design
What are the potential side effects?
Potential side effects may include complications related to mechanical ventilation such as lung damage or infections, issues due to prolonged use of corticosteroids like weakened bones or muscle weakness, and risks associated with ECMO including bleeding or blood clots.
PRACTICAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with corticosteroids for acute respiratory failure for 10 days.
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I am currently on high-flow oxygen or ventilation support.
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I am 18 years old or older.
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My low oxygen levels are not due to heart failure, fluid in lungs, or blood clots.
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I am experiencing severe difficulty breathing due to low oxygen levels.
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I am on a breathing machine but not on ECMO, meeting specific lung flexibility criteria.
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I was admitted to the ICU less than 3 days ago.
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I have had severe breathing issues with low oxygen levels for at least 6 hours.
PRACTICAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CORT-E2 domain - 60-day mortality from the day of randomization
IMV domain - adherence to LDPVS management (LANDMARK RCT)
IMV domain - probability of achieving and maintaining lung- and diaphragm-protective targets during mechanical ventilation (LANDMARK RCT)
+2 moreSecondary outcome measures
Complications from corticosteroids.
Days alive and at home to day 90
Diaphragm thickness
+25 morePRACTICAL Trial Design
3Treatment groups
Experimental Treatment
Group I: Ultra-protective ventilation facilitated by extracorporeal carbon dioxide removal (ULTIMATE) domainExperimental Treatment2 Interventions
Patients with acute hypoxemic respiratory failure in the high elastance state will be randomized to ultra-protective ventilation facilitated by extracorporeal carbon dioxide removal or to conventional lung-protective ventilation.
Group II: The Corticosteroid Early and Extended (CORT-E2) Randomized Controlled Trial domainExperimental Treatment4 Interventions
Patients with acute hypoxemic respiratory failure (AHRF) requiring invasive or non-invasive respiratory support will be randomized in the Early Cohort to receive corticosteroid or usual care without corticosteroids. Patients treated with corticosteroids who still require invasive or non-invasive respiratory support after 10 days will be randomized in the Extended Cohort to extending corticosteroid use or stopping corticosteroids after 10 days.
Group III: Invasive Mechanical Ventilation (IMV) Strategies domainExperimental Treatment3 Interventions
Patients on invasive mechanical ventilation in the low elastance, high elastance, and ECLS states will be randomized to one of two or three mechanical ventilation interventions (including conventional lung-protective ventilation as a control group). Most sites will randomize patients to two arms (one of which is the control group, LPV). A subset of sites will randomize patients to all three arms.
Find a Location
Who is running the clinical trial?
Ewan GoligherLead Sponsor
University Health Network, TorontoOTHER
1,476 Previous Clinical Trials
478,930 Total Patients Enrolled
16 Trials studying Respiratory Insufficiency
11,097 Patients Enrolled for Respiratory Insufficiency
Ewan Goligher, MD, PhDStudy ChairUniversity Health Network, Toronto
7 Previous Clinical Trials
352 Total Patients Enrolled
7 Trials studying Respiratory Insufficiency
352 Patients Enrolled for Respiratory Insufficiency
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with corticosteroids for acute respiratory failure for 10 days.I have had severe low oxygen levels for more than 6 hours.I am over 65 years old.You have new lung problems in one or both lungs.My weight is more than 1kg for every cm of my height.I cannot take certain blood thinners.I have long-term breathing problems with high CO2 levels.My care is focused on comfort and quality of life, not curing my illness.I am currently on high-flow oxygen or ventilation support.You do not use a home mechanical ventilation device, except for CPAP.I have severe breathing issues with high CO2 levels and low pH for over 6 hours.I am 18 years old or older.I need to take corticosteroids for my condition.I have not taken corticosteroids in the last 14 days.My low oxygen levels are not due to heart failure, fluid in lungs, or blood clots.I have a severe brain injury with a low consciousness level.You are allergic to dexamethasone.You are very sick and not expected to live for another day.Your blood oxygen level is high enough at the time of randomization.You have been on a breathing machine for more than 72 hours during your current hospital stay.I have been diagnosed with a neuromuscular disorder.I am on a life support machine but not on a mechanical ventilator.I am expected to be discharged from the ICU today.I have severe breathing issues with high CO2 levels and low pH for over 6 hours.I am experiencing severe difficulty breathing due to low oxygen levels.I am on a breathing machine but not on ECMO, meeting specific lung flexibility criteria.I am currently taking corticosteroids for a reason other than cancer.I was admitted to the hospital for a recent brain injury.I am expected to have my breathing tube removed today.I am expected to need a breathing machine for less than 48 hours.My breathing problems are due to COVID-19.I have been on a breathing machine for 5 days or less.You are currently on ECMO (extracorporeal membrane oxygenation) treatment.I have been diagnosed with bleeding in my lungs due to vasculitis.I have had severe low oxygen levels in my blood for more than 6 hours.My weight was under 35 kg when I was admitted to the hospital.I am on low flow oxygen therapy of 15L/min or less.You recently had a serious head injury while in the hospital.I have been on oxygen or breathing support for at least 4 hours before being considered for the trial.I use a ventilator at home but not just for sleep apnea.I was admitted to the ICU less than 3 days ago.I have had severe breathing issues with low oxygen levels for at least 6 hours.I expect to be on a breathing machine for less than 48 hours.I am suspected of or confirmed to have COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Invasive Mechanical Ventilation (IMV) Strategies domain
- Group 2: Ultra-protective ventilation facilitated by extracorporeal carbon dioxide removal (ULTIMATE) domain
- Group 3: The Corticosteroid Early and Extended (CORT-E2) Randomized Controlled Trial domain
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for the research endeavor at this time?
"Indeed, information on clinicaltrials.gov verifies that this research is actively recruiting volunteers. This study was initially launched on April 30th 2023 and most recently updated June 7th of the same year. 6250 individuals must be recruited from one medical site in order to meet their enrolment goals."
Answered by AI
What are the expected results from this medical experiment?
"This clinical research will be monitored for a period of 60 days with the primary purpose being to observe adherence to LDPVS management (LANDMARK RCT). Other goals include analyzing respiratory mechanics and gas exchange, as well as monitoring tracheostomy during index ICU admission."
Answered by AI
How many volunteers have enrolled in this clinical trial thus far?
"Affirmative. The particulars of this clinical trial published on the clinicaltrials.gov website demonstrate that, as of June 7th 2023, recruitment is still in effect. This investigation was first made visible to the public on April 30th 2023 and seeks 6250 participants from one stationing point."
Answered by AI
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