Personalized Ventilator Settings for Acute Respiratory Distress Syndrome

(PEEPECMO Trial)

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Overseen ByRobert L Owens, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal use of ventilators for individuals with Acute Respiratory Distress Syndrome (ARDS) who are on ECMO, a life support system aiding the heart and lungs. Researchers aim to determine if a personalized approach to setting the ventilator's PEEP (Personalized Positive End-Expiratory Pressure, which keeps the lungs open) is more effective than the standard method. This approach seeks to reduce further lung injury, promoting more effective healing. Individuals who have undergone or are awaiting a lung or heart transplant may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance ventilator use for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this personalized ventilator strategy is safe for patients with ARDS?

Research has shown that personalized Positive End-Expiratory Pressure (PEEP) is generally safe for patients with acute respiratory distress syndrome (ARDS). In some studies, patients who received personalized PEEP experienced no major side effects, indicating it is well-tolerated in medical settings. However, minor issues can occur. For instance, one study found that setting up the equipment might cause small problems, such as nosebleeds, in about 8.7% of cases.

While personalized PEEP can protect the lungs and improve breathing, incorrect adjustments might cause problems, especially in patients with milder illness. Overall, research indicates that when personalized PEEP is carefully managed, it can safely help reduce lung injuries from ventilation.12345

Why are researchers excited about this trial?

Researchers are excited about personalized Positive End-Expiratory Pressure (PEEP) because it tailors ventilator settings to each patient with Acute Respiratory Distress Syndrome (ARDS), potentially improving outcomes. Unlike standard ventilator settings, which use a one-size-fits-all approach, personalized PEEP adjusts the pressure to better match individual patient needs while on ECMO (extracorporeal membrane oxygenation). This customization could lead to more effective breathing support and potentially faster recovery, making it a promising advancement in ARDS treatment strategies.

What evidence suggests that personalized PEEP might be an effective treatment for ARDS?

Research has shown that customizing Positive End-Expiratory Pressure (PEEP) can improve lung function in people with Acute Respiratory Distress Syndrome (ARDS). In this trial, participants will join different treatment arms, including one with personalized PEEP settings. Studies have found that a personalized PEEP approach can enhance oxygen levels and ease lung expansion. This tailored PEEP reduces lung stress and the effort needed to breathe without causing harm. However, while higher PEEP levels might improve oxygen levels, they could also affect blood circulation. Overall, adjusting PEEP settings to fit the individual may better protect the lungs during mechanical ventilation.45678

Who Is on the Research Team?

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Mazen F Odish, M.D.

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for people with severe lung problems, like ARDS or pneumonia, who are on ECMO (a heart-lung machine) and need a ventilator to help them breathe. Participants must meet specific medical criteria set by the study team.

Exclusion Criteria

I have been on V-V ECMO for more than 72 hours.
I am not receiving full life-support measures.
Patients who are pregnant or prisoners
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to either personalized ventilator strategy or standard of care ventilation while on ECMO

Duration of ECMO run
Continuous monitoring during ECMO

Follow-up

Participants are monitored for safety and effectiveness after ECMO treatment

4 weeks
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized Positive End-Expiratory Pressure (PEEP)

Trial Overview

The study compares personalized ventilator settings (specifically adjusting PEEP levels for each patient) versus standard ventilator care in patients on ECMO to see which approach helps lungs heal better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Personalized PEEPExperimental Treatment1 Intervention
Group II: Standard of Care Ventilator Settings while on ECMOActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Personalized positive end-expiratory pressure in ... - PMC

Personalized PEEPEIT-ΔPL resulted in lower dynamic lung stress and work of breathing, without significant changes in oxygenation, CO2 clearance ...

Personalized positive-end expiratory pressure using ...

EIT-guided PEEP titration improves oxygenation in patients with ARDS. •. Individualized PEEP adjustment using EIT increases respiratory system compliance. •.

Higher versus Lower Positive End-Expiratory Pressures in ...

Higher PEEP levels may improve oxygenation and reduce ventilator-induced lung injury but may also cause circulatory depression and lung injury ...

Positive End-Expiratory Pressure May Cause Harm in Less ...

PEEP may cause harm in adult patients with ARDS whose subphenotype is characterized by less severe illness and less inflammation.

Positive end-expiratory pressure management in patients with ...

both PP and V-V ECMO are associated with improved outcomes relative to low or moderate VT alone, according to a recent meta-analysis by Sud et ...

Personalized Positive End-Expiratory Pressure and Tidal ...

Positive end-expiratory pressure and tidal volume may have a key role for the outcome of patients with acute respiratory distress syndrome.

Personalized positive end-expiratory pressure in ...

Personalized positive end-expiratory pressure (PEEP) might foster lung and diaphragm protection in patients with acute respiratory distress ...

Evaluating the safety of setting positive end-expiratory ...

Adjusting PEEP settings. Complications related to esophageal pressure catheter placement were minimal, with 8.7% nosebleeds and 2.2% ...