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Prone Positioning + HFOV for Severe Pediatric ARDS
N/A
Waitlist Available
Led By Ira M. Cheifetz, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intubated and mechanically ventilated with high moderate-severe PARDS for <48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI ≥12 or OSI ≥10)
Two blood gases meeting moderate-severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient's hemodynamic status per PALICC guidelines; specifically, incremental and decremental PEEP changes to optimize lung volume)
Must not have
Currently receiving more than 6 consecutive hours of either prone positioning or HFOV
Unstable spine, femur or pelvic fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 12 months post picu discharge
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether two different types of respiratory support - prone positioning or high-frequency oscillatory ventilation (HFOV) - are better than the current standard of care for children with severe PARDS.
Who is the study for?
This trial is for children with severe PARDS, intubated and ventilated for less than 48 hours. They must meet specific criteria indicating lung distress and not have conditions like intracranial bleeding, obstructive airway disease, recent facial trauma, unstable fractures, certain heart diseases or be on other trials.
What is being tested?
The study tests whether prone positioning or high-frequency oscillatory ventilation (HFOV) improves outcomes in children with PARDS compared to supine positioning or conventional mechanical ventilation (CMV). The goal is more days off the ventilator.
What are the potential side effects?
Potential side effects may include discomfort from position changes, skin issues at pressure points due to prolonged positioning, and risks associated with different types of mechanical ventilation such as lung injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a ventilator for less than 48 hours due to severe lung issues.
Select...
I have had two blood gas tests showing moderate to severe lung issues, following specific lung treatment guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing treatments that require me to be in a specific position for more than 6 hours.
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I have stable fractures in my spine, femur, or pelvis.
Select...
I have been diagnosed with bronchiolitis obliterans.
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I have a heart condition that causes bluish skin color.
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I have a critical airway condition or a blockage in my lower airway.
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I have an open wound in my abdomen.
Select...
I have severe lung disease without lung tissue involvement.
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I have been diagnosed with cardiomyopathy.
Select...
I am currently on a breathing machine due to severe asthma.
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I have a muscle condition that affects my breathing.
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I have had bleeding in my brain.
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My lung disease affects only one lung.
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I have high blood pressure in the lungs not caused by another condition.
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I have had a lung transplant.
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I have an untreated hole in my diaphragm or my diaphragm cannot move.
Select...
My breathing problems are due to heart failure or fluid buildup.
Select...
I have had a head injury treated with hyperventilation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, 12 months post picu discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 12 months post picu discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ventilator - respiratory equipment
Secondary study objectives
Nonpulmonary organ failure-free days (OFFD)
Other study objectives
90-day in-hospital mortality
Duration of mechanical ventilation (among survivors)
Interaction effects of prone positioning with HFOV on VFDs - number of ventilator-free days
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Supine / HVOFExperimental Treatment1 Intervention
Supine positioning and high-frequency oscillatory ventilation
Group II: Supine / CMVExperimental Treatment1 Intervention
Supine positioning and conventional mechanical ventilation
Group III: Prone / HFOVExperimental Treatment1 Intervention
Prone positioning and high-frequency oscillatory ventilation
Group IV: Prone / CMVExperimental Treatment1 Intervention
Prone positioning and conventional mechanical ventilation
Find a Location
Who is running the clinical trial?
University Medical Center GroningenOTHER
754 Previous Clinical Trials
1,076,069 Total Patients Enrolled
University Hospitals Cleveland Medical CenterOTHER
327 Previous Clinical Trials
344,444 Total Patients Enrolled
Boston Children's HospitalOTHER
788 Previous Clinical Trials
5,581,971 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,791,698 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,726,112 Total Patients Enrolled
Ira M. Cheifetz, MDPrincipal InvestigatorUH Rainbow Babies and Children's Hospital
Martha AQ Curley, RN, PhDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
1,171 Total Patients Enrolled
Martin CJ Kneyber, MD, PhDPrincipal InvestigatorBeatrix Children's Hospital
David Wypij, PhDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
2,949 Total Patients Enrolled