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Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients

NCT03202641 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-12-19

No results posted yet for this study

Summary

The goal of this interventional crossover study, in intubated and mechanically ventilated Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas exchange, changes in aeration, ventilation/perfusion matching its impact on cardiac function, especially the right heart (RH). The PEEP titration techniques are: PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet") and lung recruitment maneuver (LRM) plus PEEPdec titration based on the best compliance of the respiratory system("PEEPLRM").

Conditions

  • ARDS, Human
  • Lung Injury, Acute
  • Respiratory Distress Syndrome
  • Mechanical Ventilation Complication
  • Alveolar Edema
  • Right Heart Failure
  • Right Ventricular Dysfunction

Interventions

PROCEDURE

PEEP ARDSnet

PEEP settings based on the low PEEP/high FiO2 table

PROCEDURE

PEEP LRM

A lung recruitment maneuver (LRM) followed by PEEP guided by transpulmonary pressure.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Robert Kacmarek, RRT, PhD · Massachusetts General Hospital

  • Lorenzo Berra, MD · Massachusetts General Hospital

  • Roberta De Santis Santiago, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2020-05-12
Completion
2020-05-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202641 on ClinicalTrials.gov