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

Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome - PEGASUS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51558

Enrollment

200

Registered

2021-11-17

Start date

2022-08-09

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome Lung injury

Interventions

Within 12 hours of ARDS diagnosis, patients undergo a lung ultrasound to distinguish&nbsp

between focal and non-focal ARDS. After differentiation, patients are&nbsp

randomized into the personalized ventilation group or the control group.&nbsp

Ventilation strategies per group will be as follows: Personalized ventilation focal ARDS: - Tidal volume: 6-8 ml/kg PBW - PEEP: &lt

10 cmH2O - Mandatory prone position Personalized Ventilation Non-focal ARDS: - Tidal volume: 4-6 ml/kg PBW - PEEP: &gt

15 cmH2O&nbsp

- Mandatory recruitment manoeuvres. Control group ventilation strategy: - Tidal volume: 6 ml/kg PBW - PEEP: According to the PEEP/FiO2 table of the ALVEOLI study, with a maximum&nbsp

peak pressure below 30 cmH2O - Prone position is encouraged Except for different ventilation strategies, other aspects of treatment will be&nbsp

the same for all groups.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Age under 18, participation in an other interventional studie,  conditions in which lung ultrasound is not feasible (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, patients who are  moribund or facing end of life, pregnant patients and no informed consent.

Design outcomes

Primary

Measure	Time frame
Mortality at day 90 (day of ARDS diagnosis considered as day 0).	—

Secondary

Measure	Time frame
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, complications as a result of ventilation.	—

Countries

Bangladesh, Belgium, Denmark, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland

Contacts

Public ContactJ.S. Sinnige

Amsterdam UMC

j.s.sinnige@asmterdamumc.nl020 566 9111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026