NCT05492344 Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome
| NCT ID | NCT05492344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | ARDS, Human |
| Study Type | INTERVENTIONAL |
| Enrollment | 538 participants |
| Start Date | 2022-08-09 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 538 participants in total. It began in 2022-08-09 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Admitted to a participating ICU, * invasively ventilated and * fulfil the Berlin criteria for moderate or severe ARDS. Exclusion Criteria: * 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 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.
Contact & Investigator
Lieuwe DJ Bos, Dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT05492344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying ARDS, Human. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05492344 currently recruiting?
Yes, NCT05492344 is actively recruiting participants. Contact the research team at j.s.sinnige@amsterdamumc.nl for enrollment information.
Where is the NCT05492344 trial being conducted?
This trial is being conducted at Brussels, Belgium, Copenhagen, Denmark, Hillerød, Denmark, Athens, Greece and 6 additional locations.
Who is sponsoring the NCT05492344 clinical trial?
NCT05492344 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Lieuwe DJ Bos, Dr. at Amsterdam UMC, location AMC. The trial plans to enroll 538 participants.