The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVietnam Military Medical University

About this trial

Acute respiratory distress syndrome (ARDS) in its moderate to severe forms is associated with high mortality. Mechanical ventilation (MV) remains the cornerstone of ARDS management but carries a significant risk of ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP), a fundamental component of MV, is widely utilized in clinical practice; however, optimal PEEP selection for patients with moderate to severe ARDS remains a complex and unresolved challenge. Electrical impedance tomography (EIT), a bedside imaging modality that evaluates regional ventilation distribution, offers a means of individualizing PEEP settings in mechanically ventilated patients. By balancing the competing risks of alveolar overdistension and collapse, EIT facilitates precision in PEEP titration. This study compares the impact of EIT-guided PEEP selection versus the conventional low FiO2-PEEP table on blood oxygenation and pulmonary mechanics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Intubated moderate and severe ARDS according to the New Global Definition (PaO2/FiO2 ≤200 mmHg).

Used continuous sedation with or without paralysis.

Disqualifiers

Presence of pneumothorax that is either undrained or newly occurred.

Unstable hemodynamics with a mean arterial pressure < 60 mmHg and unresponsive to resuscitation measures, and/or heart rate < 60 bpm.

Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application).

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • electrical impedance tomography

    Device

    Before initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDSnetwork strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg. * PEEP was incrementally increased by 5 cmH2O every minute: from 10 to 15, to 20, and finally to 25 cmH2O, with a maximum pressure limit of 40 cmH2O. * Following recruitment maneuver at the final PEEP level, the process of identifying the optimal PEEP was initiated. * Then, PEEP will be set to 20 cmH2O and was gradually decreased by 2 cmH2O every 30 seconds until it reached 6 cmH2O or SpO2 dropped to ≤ 80%. * Selection of optimal PEEP: The optimal PEEP was defined as the intersection point between the alveolar overdistension and collapse curves as measured by the EIT system.

  • Non-EIT

    Other intervention

    Patients will have PEEP set using the low FiO2-PEEP table, based on the ARDSnet protocol

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: EIT-PEEP settingActive comparator 1 intervention
Group B: ARDSNet-PEEP settingPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oxygenation

PaO2/FiO2 will be evaluated via arterial blood gas analysis every day during the first week treatment.

Time frame
at day 1, 2, 3, 4, 5, 6, 7
2

Pulmonary Mechanic

Static Compliance

Time frame
at day 1, 2, 3, 4, 5, 6, 7

Secondary outcomes

1

Ventilator free days

Ventilator free days

Time frame
up to 28 days
2

Length of ICU stay

Days of ICU stay

Time frame
up to 28 days
3

Length of mechanical ventilated days

Days of received mechanical ventilation

Time frame
up to 28 days
4

Pneumothorax or barotrauma

new-onset of pneumothorax and barotrauma

Time frame
up to 28 days

Other outcomes

Sponsors and contacts

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Vietnam Military Medical University

Lead sponsor

Hanoi Medical University

Collaborator

Bach Mai Hospital

Collaborator