Mechanical Ventilation for Acute Respiratory Distress Syndrome
(PROTECT-ARDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to find a better way to protect the lungs of patients with Acute Respiratory Distress Syndrome (ARDS) who are being treated with a mechanical ventilator in addition to an extracorporeal membrane oxygenation (ECMO) machine. ARDS is a serious lung condition that makes it hard to breathe. People with ARDS often need care in the intensive care unit (ICU) and can become very sick with high mortality rates despite optimal care.
Doctors usually support patients with through ARDS with a breathing machine called a ventilator. The ventilator helps lungs imitate taking small breaths to help protect the lungs from more damage, however ventilator induced lung injury (VILI) can still contribute significantly to organ injury.
For patients in whom a ventilator is not enough support due to the severity of their lung disease, veno-venous (VV) ECMO can fully support the lungs while they recover. In these sickest patients, it is important to avoid causing more lung damage with the ventilator. Protecting the lungs may help them heal faster and may also help protect other parts of the body. More people are now being treated with VV ECMO, but there is still not enough research to know which ventilator settings are safest and work best. Most current recommendations are based on doctors' experience instead of research studies. This study will help researchers learn the best way to use ventilators for patients on VV ECMO and improve their recovery.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with severe ARDS who have been on VV ECMO and a ventilator for less than 24 hours. They must have serious breathing problems not caused by heart failure or fluid overload, and show lung inflammation in both lungs. People with prior lung transplants, certain ECMO types, pregnancy, or under 18 can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Patients are assigned to either a low mechanical power target or usual care, with ventilator settings adjusted accordingly.
Follow-up
Participants are monitored for safety and effectiveness after the intervention, including biomarker measurements and clinical outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Mechanical Power Targeted Ventilation
Trial Overview
The study tests a new way of setting the ventilator—called mechanical power targeted ventilation—to better protect the lungs of patients on VV ECMO due to severe ARDS. The goal is to find safer settings that may help recovery compared to current practices.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
This group will have their mechanical ventilator settings adjusted by the study team to a target mechanical power of between 2-4 J/minute, closely mimicking the mechanical power of that required for healthy adult breathing. The adjustments will be made using the mechanical power ventilation formula with information specific to the person, titrating each of the variables historically associated with ventilator induced lung injury in tandem. The ventilator will be monitored and adjusted as needed every 2 hours for 7 days while patients are on ECMO.
This arm will receive routine care for all aspects of care including ECMO and mechanical ventilation as decided by the attending physician.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.