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Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients
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
🗓️ Study Start (Actual) 19 June 2019
🗓️ Primary Completion (Estimated) April 2023
✅ Study Completion (Estimated) August 2024
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * ARDS diagnosis within 72h after intubation
    • * Severe to moderate ARDS (PaO2 / FiO2 \< 200 mmHg) with PEEP\>5 cmH2O
    • * Presence of an arterial line
    • * Between 18 and 85 years old

    Exclusion Criteria:

    • * Persistent systolic blood pressure \< 90 mmHg and/or \>180 mmHg despite the use of vasopressor or vasodilators
    • * Increment in vasopressors over the past two hour just before enrollment of: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine.
    • * Advanced lung disease confirmed by computed tomography findings
    • * Presence or history of pneumothorax
    • * Severe coagulopathy (INR ≥ 4)
    • * Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
    • * Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
    • * Recent esophageal trauma or surgery
    • * Known presence of esophageal varices
    • * Pregnancy
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 June 2017
  • First Submitted that Met QC Criteria 26 June 2017
  • First Posted 28 June 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 November 2022
  • Last Update Posted 10 November 2022
  • Last Verified November 2022
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