EIT-Guided PEEP Optimization in Trauma and Postoperative ARDS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNguyen Dang Thu

About this trial

Acute respiratory distress syndrome (ARDS) remains a serious and often fatal complication in patients following severe trauma or major surgery. Mechanical ventilation is essential for supportive care in this population, but may aggravate lung injury when suboptimal ventilatory settings are applied. Positive end-expiratory pressure (PEEP) is crucial for maintaining alveolar recruitment; however, optimal PEEP selection in trauma- or postoperative-associated ARDS remains uncertain. Electrical impedance tomography (EIT) enables bedside, real-time assessment of regional ventilation and may support optimal PEEP titration by balancing alveolar overdistension and collapse. This study compares EIT-guided PEEP optimization with the conventional low FiO₂-PEEP strategy in terms of oxygenation and respiratory mechanics in patients with moderate to severe ARDS following trauma or surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mechanically ventilated surgical intensive care patients with trauma- or postoperative-associated moderate to severe ARDS, as defined by the 2023 Global Definition of ARDS.

Disqualifiers

Age <18 or >90 years.

Severe acute brain injury or acute stroke with Glasgow Coma Scale <8.

Thoracic trauma with pneumothorax or pneumomediastinum.

End-stage diseases under palliative care (e.g., metastatic cancer, cirrhosis, end-stage renal disease).

Trial design

Design model

Parallel

Treatments tested in this trial

  • EIT-giuded PEEP

    Device

    Device: electrical impedance tomography system (Enlight 2100, Timpel SA, Brazil). \- Patients underwent airway suctioning and were deeply sedated (RASS ≤ -3) to abolish spontaneous breathing. PEEP titration was performed using an EIT system (Enlight 2100, Timpel SA, Brazil), with a silicone belt containing 32 surface electrodes positioned at the fourth to fifth intercostal space in accordance with the manufacturer's instructions. Pressure-controlled ventilation was applied with an inspiration pressure set at 15 cmH₂O and a set PEEP of 24 cmH₂O, with a maximum airway pressure limit of 40 cmH₂O. Ventilator settings were maintained for 30 seconds with an FiO₂ of 1.0. A decremental PEEP trial was then performed by reducing PEEP in 2 cmH₂O every 30 seconds until a PEEP of 6 cmH₂O was reached or the SpO₂ decreased to ≤ 80%. The EIT-guided optimal PEEP was defined as the PEEP level corresponding to the intersection point of the collapse and overdistension curves.

  • Control

    Device

    PEEP was set and adjusted according to the lower PEEP/FiO₂ table of the ARDS Network

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oxygenation

PaO₂/FiO₂ ratio

Time frame
at day 0, 1, 2, 3
2

Pulmonary Mechanics

Static Compliance

Time frame
at day 0, 1, 2, 3

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

Barotrauma

pneumothorax, pneumomediastinum, and subcutaneous emphysema

Time frame
up to 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nguyen Dang Thu

Lead sponsor

Vietnam Military Medical University

Sponsor institution

Hanoi Medical University

Collaborator

Viet Duc University Hospital

Collaborator