Trial overview
EITVent-2 evaluates whether the effects of EIT-guided PEEP on clinical outcomes differ by lung recruitability in patients with moderate-to-severe ARDS.
- Allocation
- 1:1, with variable block randomisation
- Stratification
- Study centre and EIT-assessed alveolar collapse, using a 25% threshold
- Sample size
- Up to 2,400 participants, with up to 9 interim analyses
- Primary outcome
- 28-day mortality
- Protocol identifier
- NCT06990477 ↗
These are planned design parameters, not current recruitment figures. This page is based on the investigator manual dated 10 June 2026.
Two PEEP strategies.
Before randomisation, all enrolled patients undergo an EIT assessment of alveolar collapse and measurement of the recruitment-to-inflation (R/I) ratio.
INTERVENTION
EIT-guided PEEP titration
After a protocol-defined recruitment manoeuvre, PEEP is selected using the intersection of the alveolar collapse and overdistension curves. Subsequent reassessment and adjustment follow the protocol.
CONTROL
Low PEEP/FiO₂ table
PEEP is set using the low PEEP/FiO₂ table to achieve the protocol-defined oxygenation targets. Recruitment manoeuvres are not routinely performed before setting PEEP.
Both groups receive protocol-defined lung-protective ventilation. Rescue treatments are determined by the clinical team according to the patient's condition and the protocol.
Who is eligible?
Participants must meet all inclusion criteria and undergo a complete assessment of exclusion criteria by the research team.
- Age 18–85 years.
- Moderate-to-severe ARDS according to the Berlin definition. Within the 24 hours before screening, PaO₂/FiO₂ ≤ 200 mmHg at PEEP ≥ 5 cmH₂O.
- ARDS diagnosed within the preceding 72 hours.
Exclusion criteria
- Expected duration of mechanical ventilation ≤ 48 hours.
- Severe chronic respiratory disease requiring long-term home oxygen therapy or non-invasive ventilation.
- Untreated pneumothorax or pneumomediastinum.
- A contraindication to EIT, such as a cardiac pacemaker.
- Severe neuromuscular junction disease.
- Haemodynamic instability: a > 30% increase in vasopressor dose within 6 hours, or a noradrenaline dose > 0.5 μg/kg/min. This is a temporary exclusion; eligibility may be reassessed once stability is achieved and maintained.
- A contraindication to hypercapnia, such as intracranial hypertension.
- Severe other organ dysfunction with an expected survival of no more than 7 days, or palliative care.
- Severe liver disease, with a Child–Pugh score ≥ 10.
- Pregnant or postpartum women.
- Refusal to participate.
Eligibility and informed consent are assessed by the research team. This website does not offer patient self-enrolment or individual treatment advice.
Outcomes and follow-up.
The primary outcome is 28-day mortality. Secondary outcomes include 60-day mortality, ventilator-free days within 28 days, and ICU and hospital outcomes. Safety assessments include barotrauma, cardiac arrest and haemodynamic instability.
- Baseline / day 0
- Consent, baseline data, EIT assessment and randomisation
- During intervention
- Protocol-defined assessments, treatment records and adverse events
- Day 28
- Primary outcome and additional clinical outcomes
- Day 60
- Follow-up outcome collection
Intervention continues until the first of the following: sustained pressure-support ventilation for 48 hours, death, discharge, withdrawal, or study day 60.