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

NCT03202641 | Terminated

• 1 other identifier: OLA-HEART
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ARDS; PEEP titration; Open Lung Strategy; Right heart function; Lung recruitment maneuver; Esophageal Pressure; Respiratory system compliance

Outcome Measures

Primary Outcomes (1)

• Driving Pressure (cmH2O)

  The primary endpoint of this study is to describe the airways driving pressures (defined as Plateau Pressure minus PEEP) during "PEEP ARDSnet" and "PEEP LRM".

  1h (Phase A: "PEEP ARDSnet") and 2h (Phase C: "PEEP LRM") after the beginning of the study procedures

Other Outcomes (10)

• Chest wall and lung elastances (cmH2O/L)

  1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures

• Dead space (%)

  1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures

• Right heart function (Transthoracic Echocardiography)

  1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures

Study Arms (1)

PEEP_titration

EXPERIMENTAL

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: 1. PEEP ARDSnet: we will select the PEEP based on low PEEP/high FiO2 table (ARDSnet). 2. PEEP LRM: we will perform a lung recruitment maneuver (LRM) and select PEEP based on transpulmonary pressure.

Procedure: PEEP ARDSnet; Procedure: PEEP LRM

Interventions

PEEP ARDSnet PROCEDURE

PEEP settings based on the low PEEP/high FiO2 table

PEEP_titration

PEEP LRM PROCEDURE

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

PEEP_titration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (19)

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  PMID: 26584196 BACKGROUND

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  PMID: 28708679 BACKGROUND

• Pinsky MR. My paper 20 years later: Effect of positive end-expiratory pressure on right ventricular function in humans. Intensive Care Med. 2014 Jul;40(7):935-41. doi: 10.1007/s00134-014-3294-8. Epub 2014 Apr 24.

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• Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.

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• Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

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MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury; Heart Failure; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Officials

• Robert Kacmarek, RRT, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Lorenzo Berra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Roberta De Santis Santiago, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Physiologic crossover study. There is no randomization.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: June 19, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)