ARDS, HumanNCT03202641
Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients
A study testing PEEP ARDSnet and PEEP LRM in people with ARDS, Human and Lung Injury, Acute, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ARDS, Human, Lung Injury, Acute, Respiratory Distress Syndrome
- What is being tested?
- PEEP ARDSnet and PEEP LRM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachussets General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients: an Open Lung is a Better Heart
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").
Read the detailed description
A recent large observational study published on JAMA showed that Acute Respiratory Distress Syndrome (ARDS) is associated with high mortality and developed in 10.4% of 29,144 patients admitted to the intensive care unit from 50 countries across 5 continents. Mechanical ventilation is the cornerstone for lung treatment during ARDS. Lung protective ventilation improved ARDS outcome significantly. However, it is still unclear what method should be used to select levels of positive end-expiratory pressure (PEEP).
In the current study proposal, the investigators hypothesized that, when ARDS lungs are recruitable, a lung recruitment maneuver (LRM) and PEEP titration ("PEEPLRM") improve ventilation/perfusion matching and decreased right heart workload when compared to the actual standard of care PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet").
The investigators will test this hypothesis in an interventional crossover study.
50 patients with ARDS will be enrolled in a physiological and lung and heart imaging study.
The protocol is divided in the following phases:
- "PEEPARDSnet": setting PEEP according to the ARDSnet table (low PEEP/ high FiO2)
- Recruitability assessment sequence:
P-V curve tool (Hamilton ventilator): evaluate patient recruitability, among three criteria, two must be positive to consider a subject recruitable: (1) Presence of a lower inflection point (2) Linear compliance measured more than 2 times higher than the dynamic compliance (3) Increase in volume of more than 300mL during the descendant limb of the PV curve at a same given pressure (20 cmH2O)(Hysteresis property).
C)"PEEPLRM": LRM plus PEEP decremental trial guided by best compliance. Lung and heart response to "PEEPLRM": we will compare the driving pressure (DP) value (DP = Plateau pressure - PEEP) and transthoracic echocardiography (TTE) with the values at PEEPARDSnet. In the advent of an increased DP and/or new onset of abnormal values at the TTE, we will resume the PEEPARDSnet settings during the 48h follow-up phase.
Before and after the lung recruitment maneuver and decremental PEEP trial, we will collect:
- Respiratory system mechanics
- Lung volumes
- Gas exchange
- Hemodynamic parameters
- Electrical Impedance Tomography (EIT) ventilation and perfusion data
- Transthoracic echocardiographic indices of RH function
Follow-up phase:
In 24 and 48 hours, if the subject did not present a negative response to "PEEPLRM" as described above , we will repeat the recruitment maneuver and the decremental PEEP trial and and we will collect:
- Respiratory system mechanics (i.e. driving pressure)
- Lung volumes
- Gas exchange
- Hemodynamic parameters
- EIT ventilation and perfusion data
- Transthoracic echocardiographic indices of RH function before and after the aforementioned intervention.
- Conditions
- ARDS, Human, Lung Injury, Acute, Respiratory Distress Syndrome, Mechanical Ventilation Complication, Alveolar Edema, Right Heart Failure
- Being tested
- PEEP ARDSnet, PEEP LRM
- Keywords
- ARDS, PEEP titration, Open Lung Strategy, Right heart function, Lung recruitment maneuver, Esophageal Pressure, Respiratory system compliance
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury, Heart Failure, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP ARDSnetProcedure or surgery
PEEP settings based on the low PEEP/high FiO2 table
PEEP LRMProcedure or surgery
A lung recruitment maneuver (LRM) followed by PEEP guided by transpulmonary pressure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PEEP ARDSnet; Procedure: PEEP LRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 1h (Phase A: "PEEP ARDSnet") and 2h (Phase C: "PEEP LRM") after the beginning of the study procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start19 Jun 2019
- Primary completion12 May 2020
- Study completion12 May 2020
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Physiologic crossover study. There is no randomization.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Berra, MD, Massachusetts General Hospital
- Investigators
- Robert Kacmarek, RRT, PhD, Principal investigator, Massachusetts General HospitalLorenzo Berra, MD, Principal investigator, Massachusetts General HospitalRoberta De Santis Santiago, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202641
- Sponsor's protocol ID
- OLA-HEART
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashbaugh DG, Bigelow DB, Petty TL, Levine BE. Acute respiratory distress in adults. Lancet. 1967 Aug 12;2(7511):319-23. doi: 10.1016/s0140-6736(67)90168-7. No abstract available.
PubMed 4143721ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Lachmann B. Open Lung in ARDS. Minerva Anestesiol. 2002 Sep;68(9):637-42; discussion 640, 643. No abstract available.
PubMed 12370679Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
PubMed 26672923Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
PubMed 24597883Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11.
PubMed 16690982de Matos GF, Stanzani F, Passos RH, Fontana MF, Albaladejo R, Caserta RE, Santos DC, Borges JB, Amato MB, Barbas CS. How large is the lung recruitability in early acute respiratory distress syndrome: a prospective case series of patients monitored by computed tomography. Crit Care. 2012 Jan 8;16(1):R4. doi: 10.1186/cc10602.
PubMed 22226331Pirrone M, Fisher D, Chipman D, Imber DA, Corona J, Mietto C, Kacmarek RM, Berra L. Recruitment Maneuvers and Positive End-Expiratory Pressure Titration in Morbidly Obese ICU Patients. Crit Care Med. 2016 Feb;44(2):300-7. doi: 10.1097/CCM.0000000000001387.
PubMed 26584196Fumagalli J, Berra L, Zhang C, Pirrone M, Santiago RRS, Gomes S, Magni F, Dos Santos GAB, Bennett D, Torsani V, Fisher D, Morais C, Amato MBP, Kacmarek RM. Transpulmonary Pressure Describes Lung Morphology During Decremental Positive End-Expiratory Pressure Trials in Obesity. Crit Care Med. 2017 Aug;45(8):1374-1381. doi: 10.1097/CCM.0000000000002460.
PubMed 28708679Pinsky 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.
PubMed 24760121Lansdorp B, Hofhuizen C, van Lavieren M, van Swieten H, Lemson J, van Putten MJ, van der Hoeven JG, Pickkers P. Mechanical ventilation-induced intrathoracic pressure distribution and heart-lung interactions*. Crit Care Med. 2014 Sep;42(9):1983-90. doi: 10.1097/CCM.0000000000000345.
PubMed 24743042Matamis D, Lemaire F, Harf A, Brun-Buisson C, Ansquer JC, Atlan G. Total respiratory pressure-volume curves in the adult respiratory distress syndrome. Chest. 1984 Jul;86(1):58-66. doi: 10.1378/chest.86.1.58.
PubMed 6734293Demory D, Arnal JM, Wysocki M, Donati S, Granier I, Corno G, Durand-Gasselin J. Recruitability of the lung estimated by the pressure volume curve hysteresis in ARDS patients. Intensive Care Med. 2008 Nov;34(11):2019-25. doi: 10.1007/s00134-008-1167-8. Epub 2008 Jun 25.
PubMed 18575846
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients: an Open Lung is a Better Heart
- ClinicalTrials.gov ID
- NCT03202641
- Acronym / sponsor ID
- OLA-HEART
- Conditions
- ARDS, Human, Lung Injury, Acute, Respiratory Distress Syndrome, Mechanical Ventilation Complication, Alveolar Edema, Right Heart Failure
- Keywords
- ARDS, PEEP titration, Open Lung Strategy, Right heart function, Lung recruitment maneuver, Esophageal Pressure, Respiratory system compliance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID pandemic
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Detailed description
A recent large observational study published on JAMA showed that Acute Respiratory Distress Syndrome (ARDS) is associated with high mortality and developed in 10.4% of 29,144 patients admitted to the intensive care unit from 50 countries across 5 continents. Mechanical ventilation is the cornerstone for lung treatment during ARDS. Lung protective ventilation improved ARDS outcome significantly. However, it is still unclear what method should be used to select levels of positive end-expiratory pressure (PEEP).
In the current study proposal, the investigators hypothesized that, when ARDS lungs are recruitable, a lung recruitment maneuver (LRM) and PEEP titration ("PEEPLRM") improve ventilation/perfusion matching and decreased right heart workload when compared to the actual standard of care PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet").
The investigators will test this hypothesis in an interventional crossover study.
50 patients with ARDS will be enrolled in a physiological and lung and heart imaging study.
The protocol is divided in the following phases:
- "PEEPARDSnet": setting PEEP according to the ARDSnet table (low PEEP/ high FiO2)
- Recruitability assessment sequence:
P-V curve tool (Hamilton ventilator): evaluate patient recruitability, among three criteria, two must be positive to consider a subject recruitable: (1) Presence of a lower inflection point (2) Linear compliance measured more than 2 times higher than the dynamic compliance (3) Increase in volume of more than 300mL during the descendant limb of the PV curve at a same given pressure (20 cmH2O)(Hysteresis property).
C)"PEEPLRM": LRM plus PEEP decremental trial guided by best compliance. Lung and heart response to "PEEPLRM": we will compare the driving pressure (DP) value (DP = Plateau pressure - PEEP) and transthoracic echocardiography (TTE) with the values at PEEPARDSnet. In the advent of an increased DP and/or new onset of abnormal values at the TTE, we will resume the PEEPARDSnet settings during the 48h follow-up phase.
Before and after the lung recruitment maneuver and decremental PEEP trial, we will collect:
- Respiratory system mechanics
- Lung volumes
- Gas exchange
- Hemodynamic parameters
- Electrical Impedance Tomography (EIT) ventilation and perfusion data
- Transthoracic echocardiographic indices of RH function
Follow-up phase:
In 24 and 48 hours, if the subject did not present a negative response to "PEEPLRM" as described above , we will repeat the recruitment maneuver and the decremental PEEP trial and and we will collect:
- Respiratory system mechanics (i.e. driving pressure)
- Lung volumes
- Gas exchange
- Hemodynamic parameters
- EIT ventilation and perfusion data
- Transthoracic echocardiographic indices of RH function before and after the aforementioned intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Physiologic crossover study. There is no randomization.
| Arm | Type | Receives |
|---|---|---|
| PEEP_titration | Experimental | Procedure: PEEP ARDSnet, Procedure: PEEP LRMThere 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP ARDSnetPEEP settings based on the low PEEP/high FiO2 table | Procedure or surgery | PEEP_titration |
| PEEP LRMA lung recruitment maneuver (LRM) followed by PEEP guided by transpulmonary pressure. | Procedure or surgery | PEEP_titration |
Primary outcome
Driving Pressure (cmH2O)
Time frame: 1h (Phase A: "PEEP ARDSnet") and 2h (Phase C: "PEEP LRM") after the beginning of the study procedures
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".
Results and safety
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 4143721Ashbaugh DG, Bigelow DB, Petty TL, Levine BE. Acute respiratory distress in adults. Lancet. 1967 Aug 12;2(7511):319-23. doi: 10.1016/s0140-6736(67)90168-7. No abstract available.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 12370679Lachmann B. Open Lung in ARDS. Minerva Anestesiol. 2002 Sep;68(9):637-42; discussion 640, 643. No abstract available.
- Background: PubMed 26672923Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 24597883Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
- Background: PubMed 16690982Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11.
- Background: PubMed 22226331de Matos GF, Stanzani F, Passos RH, Fontana MF, Albaladejo R, Caserta RE, Santos DC, Borges JB, Amato MB, Barbas CS. How large is the lung recruitability in early acute respiratory distress syndrome: a prospective case series of patients monitored by computed tomography. Crit Care. 2012 Jan 8;16(1):R4. doi: 10.1186/cc10602.
- Background: PubMed 26584196Pirrone M, Fisher D, Chipman D, Imber DA, Corona J, Mietto C, Kacmarek RM, Berra L. Recruitment Maneuvers and Positive End-Expiratory Pressure Titration in Morbidly Obese ICU Patients. Crit Care Med. 2016 Feb;44(2):300-7. doi: 10.1097/CCM.0000000000001387.
- Background: PubMed 28708679Fumagalli J, Berra L, Zhang C, Pirrone M, Santiago RRS, Gomes S, Magni F, Dos Santos GAB, Bennett D, Torsani V, Fisher D, Morais C, Amato MBP, Kacmarek RM. Transpulmonary Pressure Describes Lung Morphology During Decremental Positive End-Expiratory Pressure Trials in Obesity. Crit Care Med. 2017 Aug;45(8):1374-1381. doi: 10.1097/CCM.0000000000002460.
- Background: PubMed 24760121Pinsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kacmarek, RRT, PhD principal investigator
Massachusetts General Hospital
Lorenzo Berra, MD principal investigator
Massachusetts General Hospital
Roberta De Santis Santiago, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP ARDSnet and PEEP LRM in people with ARDS, Human and Lung Injury, Acute, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving Pressure (cmH2O) (time frame: 1h (Phase A: "PEEP ARDSnet") and 2h (Phase C: "PEEP LRM") after the beginning of the study procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202641, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.