Skip to content

Effect of EIT-guided PEEP in ARDS Patients

Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients: a Multicenter Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06990477
Enrollment
2400
Registered
2025-05-25
Start date
2026-03-13
Completion date
2030-02-20
Last updated
2026-07-10

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

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Brief summary

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in ARDS patients.

Interventions

PEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O or to 24cmH2O and then reduced in steps of 2cmH2O from 20 to 4 every 30s.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Age≥18 years 2. Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen \[PaO2\]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O) 3. Diagnosis of ARDS less than 72 hours

Exclusion criteria

1. Expected to be mechanically ventilated for less than 48 hours 2. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV 3. Undrained pneumothorax or subcutaneous emphysema 4. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps) 5. Severe neuromuscular disease 6. Hemodynamic instability 7. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome 8. Severe other organs dysfunction with a low expected survival (7 days) or palliative care 9. Severe liver disease (Child-Pugh Score ≥10) 10. Pregnancy 11. Refusal to sign the informed consent

Design outcomes

Primary

MeasureTime frame
28-day mortalitymortality in Day 28

Countries

China, South Korea, Taiwan

Contacts

CONTACTyuan xue yan, MD, MD
18826401594@163.com+86 83262550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026