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

Southeast University, China

Status: Not yet enrolling

Conditions: ARDS (Acute Respiratory Distress Syndrome)

Treatments: Device: EIT-guided PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT06990477

EITVent2

Details and patient eligibility

About

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 patients with higher recruitability.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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. Patients with tidal volume of 6 mL/Kg would require a driving pressure of ≥ 13 cmH2O and the percentage of collapse monitoring by EIT >25%
4. 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. Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
5. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
6. Severe neuromuscular disease
7. Hemodynamic instability
8. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
9. Severe other organs dysfunction with a low expected survival (7 days) or palliative care
10. Solid organ or hematologic tumors with the expected survival time less than 30 days
11. Participating in other clinical trials within 30 days
12. Pregnancy
13. Refusal to sign the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

EIT-guided group

Experimental group

Description:

Patients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial

Treatment:

Device: EIT-guided PEEP

low PEEP-FiO2 table group

No Intervention group

Description:

PEEP will be set according to the low FiO2-PEEP table to keep the oxygenation goals: SpO2 between 88% and 95%, and PaO2 between 55mmHg and 80mmHg.