In the PEGASUS study, all rewards will be shared. There will be one co-author spot for each center that includes a patient. Each center will receive an additional co-author sport per 20 inclusions. The steering committee and international advisory committee (national coordinators), will also receive a co-author spot.
Correct lung ultrasound assessment of lung morphology is crucial for the PEGASUS study. In each center, the local study coordinator will receive an E-learning with exam and will need to upload a case exam before enrolment can be started. The PEGASUS study team will offer live lung ultrasound support for the first two inclusions and more if needed.
Around 40-50 centers will include patients for the PEGASUS study, resulting in around 10 inclusions per center.
ARDS is diagnosed by the treating physician. After the physician recognizes that a patients fulfils the Berlin criteria for moderate/severe ARDS, the patient needs to be randomized within 12 hours.
Yes, but only if the other RCT does not have mortality/duration of ventilation as primary outcome.
No, patients on ECCO2R can be included, but ECMO is an exclusion criterion.
In patients with focal lung morphology in the personalized study arm, lung ultrasound will be repeated after 2-3 days to assess if a patient did not develop non-focal lung morphology. If a patient switched to non-focal lung morphology at the second ultrasound, personalized ventilation will be aligned with non-focal lung morphology.
Lung ultrasound will not be repeated in patients with non-focal lung morphology in the personalized arm as switching from non-focal to focal lung morphology is considered as a direct effect of the study intervention.
Non-focal group:
- If patients are breathing spontaneously, PEEP may be decreased from at least 15 cmH2O to 10 cmH2O.
- PEEP may be reduced when the PaO2/FiO2 in supine position is > 200 mmHg and FiO2 is < 50%.
Focal group:
- Prone positioning may be stopped when the PaO2/FiO2 in supine position is > 200 mmHg, FiO2 is < 50% and PEEP is 5 cmH2O.
Yes, adaptive ventilation is allowed when the tidal volume and PEEP are set according to study protocol.
Use of rescue therapies is up to the discretion of the treating physician. We recommend use of rescue therapies in the following situations:
Non-focal personalized group:
- Prone positioning can be used as rescue therapy when the PaO2/FiO2 < 150 for 6 hours in supine position and FiO2 is already > 80%.
- We also advice to lower the PEEP below 15 cmH2O when patients have a plateau pressure of 30 cmH2O during an inspiratory hold.
Focal personalized group:
- PEEP can be increased > 9 cmH2O and recruitment can be used as a rescue therapy when the PaO2/FiO2 < 100 in prone position and FiO2 is already > 80%.
Occurrence of (serious) adverse events are captured within the eCRF in Castor. Events and complications that will be collected are: ventilator associated pneumonia, pneumothorax, ECMO, renal replacement therapy, inhaled vasodilators, airway pressure release ventilation and tracheostomy.
Local monitoring has the preference because of the language and access to the patient information system.