ARDS, HumanNCT05492344
Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome
A study testing Personalized ventilation in people with ARDS, Human and Lung Ultrasound, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 11 sites in 8 countries.
Trial summary
Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- ARDS, Human, Lung Ultrasound, Mechanical Ventilation
- What is being tested?
- Personalized ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 9 Aug 2022to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to a participating ICU,
- invasively ventilated and
- fulfil the Berlin criteria for moderate or severe ARDS.
Who cannot join
- Age under 18,
- participation in other interventional studies with conflicting endpoints,
- conditions in which LUS is not feasible or possible (e.g. subcutaneous emphysema, morbid obesity or wounds),
- mechanical ventilation for longer than 7 consecutive days in the past 30 days,
- history of ARDS in the previous month,
- body-mass index higher than 40 kg/m²,
Show all 16Show fewer
- intracranial hypertension,
- broncho-pleural fistula,
- chronic respiratory diseases requiring long-term oxygen therapy or respiratory support,
- pulmonary fibrosis with a vital capacity < 50% (severe or very severe),
- previously randomized in the PEGASUS study
- ECMO
- patients who receive invasive ventilation in home setting due to a neurological disease
- pregnant patients
- patients who are moribund or facing end of life and
- no informed consent.
Trial locations and contacts
11 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 8 countries
Denmark2 sites, 2 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen
Theis Skovsgaard Itenov, Dr.
- Recruiting
Nordsjaellands Hospital
Hillerød
Lars Hein, Drs.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Bari
Marco Pezzuto, Drs.
- Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari
Claudio Zimatore, Drs.
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081HV
Pieter Roel Tuinman, Dr.
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Jante Sinnige, MD, j.s.sinnige@amsterdamumc.nl
Belgium1 site, 1 recruiting
- Recruiting
Chu-Brugmann
Brussels
Charalampos Pierrakos, Dr.
China1 site, 1 recruiting
- Not yet recruiting
West China Hospital
Chengdu
S. Zhang, Dr.
Greece1 site, 1 recruiting
- Recruiting
Evaggelismos Hospital
Athens
Eleni Ischaki, Dr.
Ireland1 site, 1 recruiting
- Recruiting
Galway University Hospitals
Galway
John Laffey, Prof.
Poland1 site, 1 recruiting
- Recruiting
Centralny Szpital Kliniczny MSWiA
Warsaw
Konstanty Szuldrzynski, Prof.
About this study
Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.
Read the detailed description
Objective The aim of this study is to determine if personalized mechanical ventilation based on lung morphology assessed by LUS leads to a reduced mortality compared to conventional mechanical ventilation in ARDS patients.
Study design The PEGASUS study is an investigator-initiated multicenter randomized clinical trial (RCT) with a predefined feasibility and safety evaluation after a pilot phase.
Study population This study will include 538 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with moderate or severe ARDS. There will be a predefined feasibility and safety evaluation after inclusion of the first 80 patients.
Intervention Patients will receive a LUS exam within 12 hours after diagnosis of ARDS to classify lung morphology as focal or non-focal ARDS. Immediately after the LUS exam patients will be randomly assigned to the intervention group, with personalized mechanical ventilation, or the control group, in which patients will receive standard care.
Main study parameters/endpoints The primary endpoint is all cause mortality at day 90 (diagnosis of ARDS considered as day 0). Secondary outcomes are mortality at 28 days, ventilator free days (VFD) at day 28, ICU length of stay, ICU mortality, hospital length of stay, hospital mortality and number of complications (VAP, pneumothorax and need for rescue therapy). After a pilot phase, feasibility of LUS, correct interpretation of LUS images and correct application of the intervention within the safe limits of mechanical ventilation is evaluated to inform a stop-go decision.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Patient burden and risks are low as the ventilation methods in this study are already commonly used in ICU practice; the collection of general data from hospital charts and (electronic) medical records systems causes no harm to the patients; LUS is not uncomfortable.
- Conditions
- ARDS, Human, Lung Ultrasound, Mechanical Ventilation
- Being tested
- Personalized ventilation, Standard care
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ventilationOther
Patients who are randomized for personalized ventilation with FOCAL ARDS will receive the following ventilator settings:
- Positive end-expiratory pressure (PEEP) ≤ 9 cm water (H2O)
- Tidal volume: 6 to 8 mL/kg predicted body weight (PBW)
- Daily prone positioning
LUS will be repeated every 48-72 hours in supine position for the focal ARDS patients to assess whether they have developed non-focal ARDS during admission. In that case, patients will from then on be treated according non-focal personalized treatment protocol.
Patients who are randomized for personalized ventilation with Non-FOCAL ARDS will receive the following ventilator settings:
- PEEP ≥ 15 cm H2O
- Tidal volume: 4 to 6 mL/kg PBW
- Daily recruitment maneuver
Standard careOther
Patient who are randomized in the control group will receive standard care
- Tidal volume: 6 mL/kg PBW
- PEEP and FiO2 according to the low PEEP and high fraction of inspired oxygen (FiO2) table of the AlVEOLI study
- Prone positioning if the Partial Pressure of Oxygen (PaO2) /FiO2 ratio is < 150 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Personalized ventilation | Experimental | If a patient is assigned to the intervention group, ventilator settings will be adjusted based on the lung morphology (focal or non focal) results of the lung ultrasound. Receives: Other: Personalized ventilation |
| Standard care | Active comparator | Patients assigned to the control group will be ventilated according to the current standard of care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Any death during ICU- or hospital-stay at day 90
Measured: 90 days after inclusion
Secondary outcomes (9)
All-cause mortality
Any death during ICU- or hospital-stay at day 28
Measured: 28 days after inclusion
Ventilator free days
Duration of ventilation in survivors
Measured: 28 days after inclusion
ICU length of stay
Length of stay in the intensive care unit
Measured: 90 days after inclusion
ICU mortality
Mortality in the ICU
Measured: 90 days after inclusion
Hospital length of stay
Length of stay in the hospital
Measured: 90 days after inclusion
Hospital mortality
Mortality in the hospital
Measured: 90 days after inclusion
Number of patients with Complications
Ventilator associated pneumonia and pneumothorax
Measured: 90 days after inclusion
Number of patients with Adjunctive therapies
Extracorporeal membrane oxygenation (ECMO), recruitment, prone position
Measured: 90 days after inclusion
Number of patients with Rescue therapies
Inhaled vasodilators, airway pressure release ventilation
Measured: 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start9 Aug 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Lieuwe DJ Bos, Dr., Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492344
- Sponsor's protocol ID
- PEGASUS
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinnige JS, Smit MR, Alam MJ, Chowdhury MNH, Costa V, de Castro HSMB, Daszuta D, Filippini DFL, Ghose A, de Grooth HJ, Hein L, Hermans G, Hildebrandt T, Itenov TS, Ischaki E, Klompmaker P, Laffey J, McMahon A, McNicholas B, Mousa A, Paulus F, Pedersen UG, Pellegrini M, Pezzuto M, Povoa P, Pierrakos C, Pisani L, Roca O, Schultz MJ, Spadaro S, Szuldrzynski K, Theodorou E, Tuinman PR, Wamberg CA, Zimatore C, Bos LDJ; PEGASUS investigators. Personalized mechanical ventilation guided by lung ultrasound in patients with ARDS: a pilot phase of a randomized clinical trial. Intensive Care Med Exp. 2025 Dec 22;13(1):135. doi: 10.1186/s40635-025-00835-8.
PubMed 41423518Sinnige JS, Smit MR, Ghose A, de Grooth HJ, Itenov TS, Ischaki E, Laffey J, Paulus F, Povoa P, Pierrakos C, Pisani L, Roca O, Schultz MJ, Szuldrzynski K, Tuinman PR, Zimatore C, Bos LDJ; PEGASUS investigators. Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial. Trials. 2024 May 7;25(1):308. doi: 10.1186/s13063-024-08140-7.
PubMed 38715118
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05492344
- Acronym / sponsor ID
- PEGASUS
- Conditions
- ARDS, Human, Lung Ultrasound, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 8 Aug 2022 (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.
Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.
Detailed description
Objective The aim of this study is to determine if personalized mechanical ventilation based on lung morphology assessed by LUS leads to a reduced mortality compared to conventional mechanical ventilation in ARDS patients.
Study design The PEGASUS study is an investigator-initiated multicenter randomized clinical trial (RCT) with a predefined feasibility and safety evaluation after a pilot phase.
Study population This study will include 538 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with moderate or severe ARDS. There will be a predefined feasibility and safety evaluation after inclusion of the first 80 patients.
Intervention Patients will receive a LUS exam within 12 hours after diagnosis of ARDS to classify lung morphology as focal or non-focal ARDS. Immediately after the LUS exam patients will be randomly assigned to the intervention group, with personalized mechanical ventilation, or the control group, in which patients will receive standard care.
Main study parameters/endpoints The primary endpoint is all cause mortality at day 90 (diagnosis of ARDS considered as day 0). Secondary outcomes are mortality at 28 days, ventilator free days (VFD) at day 28, ICU length of stay, ICU mortality, hospital length of stay, hospital mortality and number of complications (VAP, pneumothorax and need for rescue therapy). After a pilot phase, feasibility of LUS, correct interpretation of LUS images and correct application of the intervention within the safe limits of mechanical ventilation is evaluated to inform a stop-go decision.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Patient burden and risks are low as the ventilation methods in this study are already commonly used in ICU practice; the collection of general data from hospital charts and (electronic) medical records systems causes no harm to the patients; LUS is not uncomfortable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized ventilation | Experimental | Other: Personalized ventilationIf a patient is assigned to the intervention group, ventilator settings will be adjusted based on the lung morphology (focal or non focal) results of the lung ultrasound. |
| Standard care | Active comparator | Other: Standard carePatients assigned to the control group will be ventilated according to the current standard of care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to a participating ICU,
- invasively ventilated and
- fulfil the Berlin criteria for moderate or severe ARDS.
Key exclusion criteria (16 listed)
- Age under 18,
- participation in other interventional studies with conflicting endpoints,
- conditions in which LUS is not feasible or possible (e.g. subcutaneous emphysema, morbid obesity or wounds),
- mechanical ventilation for longer than 7 consecutive days in the past 30 days,
- history of ARDS in the previous month,
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 |
|---|---|---|
| Personalized ventilationPatients who are randomized for personalized ventilation with FOCAL ARDS will receive the following ventilator settings: * Positive end-expiratory pressure (PEEP) ≤ 9 cm water (H2O) * Tidal volume: 6 to 8 mL/kg predicted body weight (PBW) * Daily prone positioning LUS will be repeated every 48-72 hours in supine position for the focal ARDS patients to assess whether they have developed non-focal ARDS during admission. In that case, patients will from then on be treated according non-focal personalized treatment protocol. Patients who are randomized for personalized ventilation with Non-FOCAL ARDS will receive the following ventilator settings: * PEEP ≥ 15 cm H2O * Tidal volume: 4 to 6 mL/kg PBW * Daily recruitment maneuver | Other | Personalized ventilation |
| Standard carePatient who are randomized in the control group will receive standard care * Tidal volume: 6 mL/kg PBW * PEEP and FiO2 according to the low PEEP and high fraction of inspired oxygen (FiO2) table of the AlVEOLI study * Prone positioning if the Partial Pressure of Oxygen (PaO2) /FiO2 ratio is < 150 mmHg | Other | Standard care |
Primary outcome
All-cause mortality
Time frame: 90 days after inclusion
Any death during ICU- or hospital-stay at day 90
9 secondary outcomes
All-cause mortality
Time frame: 28 days after inclusion
Ventilator free days
Time frame: 28 days after inclusion
ICU length of stay
Time frame: 90 days after inclusion
ICU mortality
Time frame: 90 days after inclusion
Hospital length of stay
Time frame: 90 days after inclusion
Hospital mortality
Time frame: 90 days after inclusion
Number of patients with Complications
Time frame: 90 days after inclusion
Number of patients with Adjunctive therapies
Time frame: 90 days after inclusion
Number of patients with Rescue therapies
Time frame: 90 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 41423518Sinnige JS, Smit MR, Alam MJ, Chowdhury MNH, Costa V, de Castro HSMB, Daszuta D, Filippini DFL, Ghose A, de Grooth HJ, Hein L, Hermans G, Hildebrandt T, Itenov TS, Ischaki E, Klompmaker P, Laffey J, McMahon A, McNicholas B, Mousa A, Paulus F, Pedersen UG, Pellegrini M, Pezzuto M, Povoa P, Pierrakos C, Pisani L, Roca O, Schultz MJ, Spadaro S, Szuldrzynski K, Theodorou E, Tuinman PR, Wamberg CA, Zimatore C, Bos LDJ; PEGASUS investigators. Personalized mechanical ventilation guided by lung ultrasound in patients with ARDS: a pilot phase of a randomized clinical trial. Intensive Care Med Exp. 2025 Dec 22;13(1):135. doi: 10.1186/s40635-025-00835-8.
- Derived from this study: PubMed 38715118Sinnige JS, Smit MR, Ghose A, de Grooth HJ, Itenov TS, Ischaki E, Laffey J, Paulus F, Povoa P, Pierrakos C, Pisani L, Roca O, Schultz MJ, Szuldrzynski K, Tuinman PR, Zimatore C, Bos LDJ; PEGASUS investigators. Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial. Trials. 2024 May 7;25(1):308. doi: 10.1186/s13063-024-08140-7.
- Individual participant dataSharing planned: Undecided
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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.
Lieuwe DJ Bos, Dr. principal investigator
Amsterdam UMC, location AMC
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized ventilation in people with ARDS, Human and Lung Ultrasound, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 11 sites in 8 countries.
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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark, Italy, Netherlands, Belgium, China and 3 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jante S Sinnige, M.D. (+31637405311, j.s.sinnige@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 90 days after inclusion). 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 NCT05492344, which also lists 2 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 15 Oct 2026.