Intensive Care Center, Bach Mai Hospital
Hanoi, Vietnam
Location status: Recruiting
NCT Number: NCT06733168
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hanoi, Vietnam
Location status: Recruiting
This is a prospective, single-center, randomized controlled trial designed to evaluate the effects of PEEP settings guided by electrical impedance tomography (EIT) on clinical outcomes in patients with moderate to severe ARDS undergoing lung-protective ventilation. Adult intubated patients with moderate to severe ARDS will be enrolled in the study.
Patients in the intervention group will receive PEEP titrated using EIT with a stepwise decremental PEEP trial, while those in the control group will have PEEP set based on the FiO2-PEEP table. Other ventilator parameters will be managed according to the ARDSnet protocol.
The primary outcomes are blood oxygenation and pulmonary mechanics. Secondary outcomes include 28-day mortality, ventilator-free and shock-free days at 28 days, length of ICU and hospital stay, rate of successful weaning, the proportion requiring rescue therapies, complications, respiratory variables, and the Sequential Organ Failure Assessment (SOFA) score.
Before initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDS network strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg.
Low FiO2 - PEEP table In the control group, patients set PEEP by low FiO2-PEEP table based on ARDSnet protocol.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients will have PEEP set using the low FiO2-PEEP table, based on the ARDSnet protocol
Time frame: at day 1, 2, 3, 4, 5, 6, 7
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
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
new-onset of pneumothorax and barotrauma
Time frame: up to 7 days
Neuromuscular blocker, prone postition, ECMO
Time frame: at day 1, 3, 7
Sequential Organ Failure Assessment
Time frame: up to 2 months
the survival rate(survival/total) during hospital stay
Contact information is provided by the study sponsor or research team.
Vietnam Military Medical University
Other
Acronym: PEEP
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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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