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PEEP Strategies for ARDS

N/A

Recruiting

Led By Roberta De Santis Santiago, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 18 and 85 years old

ARDS diagnosis within 72h after intubation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1h (phase a: "peep ardsnet"), 2h (phase c: "peep lrm"), 24h and 48h after the beginning of the study procedures

Awards & highlights

Study Summary

This trial is testing two different ways of setting the level of positive end-expiratory pressure (PEEP) in people with acute respiratory distress syndrome (ARDS), to see which one results in better lung function and heart function.

Who is the study for?

This trial is for adults aged 18-85 with a recent ARDS diagnosis, who are on mechanical ventilation and have moderate to severe symptoms (low oxygen levels even with support). They must have an arterial line in place. Excluded are those with a history of serious lung disease, severe bleeding disorders, very low or high blood pressure despite medication, extreme thrombocytopenia, electric device implants like pacemakers, recent increases in certain medications for blood pressure control, esophageal trauma or surgery, esophageal varices or pregnancy.Check my eligibility

What is being tested?

The study tests two methods of setting the ventilator's PEEP in ARDS patients: 'PEEPARDSnet' follows a standard low PEEP/high oxygen guideline while 'PEEPLRM' involves increasing PEEP until the lungs inflate most effectively. The effects on lung function and heart performance—particularly the right side—are compared.See study design

What are the potential side effects?

Potential side effects may include discomfort from higher airway pressures leading to barotrauma (lung injury due to overinflation), changes in blood gases that could affect organ function including the heart and kidneys. There might also be risks associated with frequent adjustments of ventilator settings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I was diagnosed with ARDS within 3 days after being put on a ventilator.

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My lung condition requires high levels of oxygen and breathing support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1h (phase a: "peep ardsnet"), 2h (phase c: "peep lrm"), 24h and 48h after the beginning of the study procedures

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1h (phase a: "peep ardsnet"), 2h (phase c: "peep lrm"), 24h and 48h after the beginning of the study procedures

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1h (phase a: "peep ardsnet"), 2h (phase c: "peep lrm"), 24h and 48h after the beginning of the study procedures for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Driving Pressure (cmH2O)

Other outcome measures

Central venous pressure

Chest wall and lung elastances (cmH2O/L)

Days free of mechanical ventilation

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PEEP_titrationExperimental Treatment2 Interventions

There is no randomization in this interventional, crossover, physiological study. All participants will receive the same procedures in the same order. The investigators will compare two PEEPs ("PEEPARDSnet" vs. "PEEPLRM"). Interventions: PEEP ARDSnet: we will select the PEEP based on low PEEP/high FiO2 table (ARDSnet). PEEP LRM: we will perform a lung recruitment maneuver (LRM) and select PEEP based on transpulmonary pressure.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,431 Total Patients Enrolled

3 Trials studying Pulmonary Edema

174,016 Patients Enrolled for Pulmonary Edema

Roberta De Santis Santiago, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Robert Kacmarek, RRT, PhDPrincipal InvestigatorMassachusetts General Hospital

3 Previous Clinical Trials

95 Total Patients Enrolled

Media Library

PEEP ARDSnet Clinical Trial Eligibility Overview. Trial Name: NCT03202641 — N/A

Pulmonary Edema Research Study Groups: PEEP_titration

Pulmonary Edema Clinical Trial 2023: PEEP ARDSnet Highlights & Side Effects. Trial Name: NCT03202641 — N/A

PEEP ARDSnet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03202641 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial currently enrolling participants?

"As indicated on clinicaltrials.gov, this study is presently in search for participants and was first made available to the public on June 19th 2019 with a later update taking place on November 8th 2022."

Answered by AI

What is the current number of participants in this research endeavor?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical study first posted in June 2019 is currently recruiting patients; 50 of which need to be sourced from a single site. The trial was most recently updated on November 8th 2022."

Answered by AI

Is the age restriction for this investigation restricted to below 35 years?

"In order to be eligible for this trial, individuals must have reached the age of majority and yet not exceeded 85 years old."

Answered by AI

May I volunteer for this research project?

"This clinical trial is inviting 50 patients with acute respiratory distress syndrome aged 18 to 85, who meet the criteria of a PaO2 / FiO2 < 200 mmHg and PEEP>5 cmH2O, have been intubated within 72 hours prior to diagnosis, possess an arterial line, and fall between the age range specified."

Answered by AI