Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome

NCT05492344 | Recruiting DMC

• 1 other identifier: PEGASUS
• Study Type: interventional
• Target: 538
• Locations: 7 countries
• Sites: 10

Brief 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 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.

Conditions

ARDS, Human; Lung Ultrasound; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Any death during ICU- or hospital-stay at day 90

  90 days after inclusion

Secondary Outcomes (9)

• All-cause mortality

  28 days after inclusion

• Ventilator free days

  28 days after inclusion

• ICU length of stay

  90 days after inclusion

• ICU mortality

  90 days after inclusion

• Hospital length of stay

  90 days after inclusion

Study Arms (2)

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.

Other: Personalized ventilation

Standard care

ACTIVE COMPARATOR

Patients assigned to the control group will be ventilated according to the current standard of care.

Other: Standard care

Interventions

Personalized ventilation OTHER

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

Personalized ventilation

Standard care OTHER

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

Standard care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to a participating ICU,
• invasively ventilated and
• fulfil the Berlin criteria for moderate or severe ARDS.

You may not qualify if:

• 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,
• 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 are moribund or facing end of life and
• no informed consent.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (10)

Chu-Brugmann

Brussels, Belgium

RECRUITING

Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

Nordsjaellands Hospital

Hillerød, Denmark

RECRUITING

Evaggelismos Hospital

Athens, Greece

RECRUITING

Galway University Hospitals

Galway, Ireland

RECRUITING

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Bari, Italy

RECRUITING

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

RECRUITING

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Centralny Szpital Kliniczny MSWiA

Warsaw, Poland

RECRUITING

Related Publications (2)

• 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.

  PMID: 41423518 DERIVED

• Sinnige 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.

  PMID: 38715118 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lieuwe DJ Bos, Dr.

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jante S Sinnige, M.D.

CONTACT

+31637405311; j.s.sinnige@amsterdamumc.nl

Marry R Smit, Dr.

CONTACT

+3120 5666339; m.r.smit@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 8, 2022
• Study Start: August 9, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-10

Locations

IT (2); NL (2); IE (1); PL (1); GR (1); BE (1); DK (2)