Center for Anesthesia and Surgical Intensive Care, Viet Duc University Hospital
Hanoi, 10000, Vietnam
Location status: Recruiting
NCT Number: NCT07313644
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Hanoi, 10000, Vietnam
Location status: Recruiting
This single-center, prospective, randomized controlled trial was designed to evaluate whether EIT-guided PEEP titration improves clinical outcomes in patients with trauma- or postoperative-associated ARDS. Adult intubated patients with moderate to severe ARDS were enrolled.
Patients in the intervention group received PEEP settings guided by electrical impedance tomography, whereas those in the control group were managed according to the lower PEEP/FiO₂ table of the ARDS Network. Other ventilatory parameters and oxygenation targets were set in accordance with ARDS Network recommendations. Supportive care and post-trial PEEP management followed standard ARDS treatment protocols.
The primary outcomes included oxygenation and respiratory mechanics. The secondary outcomes comprised 28-day survival, ventilator-free days at day 28, length of ICU and length of hospital stay, rate of successful ventilator weaning, use of adjunctive therapies (prone positioning, neuromuscular blockade, ECMO), newly developed barotrauma (pneumothorax, pneumomediastinum, and subcutaneous emphysema) excluding cases attributable to invasive procedures) and changes in the SOFA score.
In the intervention group, PEEP was titrated under the guidance of electrical impedance tomography (EIT) according to a protocol:
Criteria for discontinuing: PEEP titration was terminated if any of the following occurred: a sustained decrease in mean arterial pressure of > 20 mmHg from baseline, SpO₂ < 88%, or the onset of new cardiac arrhythmias. If the event of discontinuation of the procedure, all ventilator settings were reverted to those applied prior to initiation of the PEEP titration.
In the control group, PEEP was set directly and adjusted according to the lower PEEP/FiO₂ table of the ARDS Network.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device: electrical impedance tomography system (Enlight 2100, Timpel SA, Brazil).
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.
PEEP was set and adjusted according to the lower PEEP/FiO₂ table of the ARDS Network
Time frame: at day 0, 1, 2, 3
PaO₂/FiO₂ ratio
Time frame: at day 0, 1, 2, 3
Static Compliance
Time frame: up to 28 days
Ventilator free days
Time frame: up to 28 days
Days of ICU stay
Time frame: up to 28 days
Days of received mechanical ventilation
Time frame: up to 28 days
pneumothorax, pneumomediastinum, and subcutaneous emphysema
Time frame: up to 7 days
Neuromuscular blocker using, prone postition, ECMO
Time frame: at day 0, 1, 2, 3
Sequential Organ Failure Assessment
Time frame: up to 28 days
In-hospital mortality rate
Interested in participating?
Request InfoNguyen Dang Thu
Other
Electrical Impedance Tomography-Guided Positive End-Expiratory Pressure Optimization in Patients With Trauma-Related and Postoperative Acute Respiratory Distress Syndrome
Acronym: EIT-PEEP-SURG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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