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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06733168
Acronym
PEEP
Enrollment
76
Registered
2024-12-13
Start date
2024-08-15
Completion date
2026-12-30
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Syndrome Distress, Electrical Impedance Tomography (EIT), Mechanical Ventilation, Positive End-Expiratory Pressure

Keywords

Acute respiratory syndrome distress, Mechanical Ventilation, Positive End-Expiratory Pressure, electrical impedance tomography, blood oxygenation, pulmonary mechanics

Brief summary

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.

Detailed description

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. * Patients received sedation and neuromuscular blockade to achieve full synchronization with the ventilator (RASS ≤ -3). * The mode was set to Pressure-Controlled Ventilation (PCV): ΔP = 15 cmH2O, which was maintained constant during the recruitment maneuver, while FiO2, PEEP, and respiratory rate were kept as previously set. * 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 the 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 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. * Termination Criteria: If persistent hypotension (mean arterial pressure decrease \> 15 mmHg) or sustained hypoxemia (SpO2 \< 85% for at least 1 minute) occurs during the recruitment maneuver maneuver, the procedure is terminated, and ventilator settings are returned to the parameters used prior to the recruitment maneuver. Low FiO2 - PEEP table In the control group, patients set PEEP by low FiO2-PEEP table based on ARDSnet protocol.

Interventions

DEVICEelectrical impedance tomography

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.

OTHERNon-EIT

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

Sponsors

Hanoi Medical University
CollaboratorOTHER
Bach Mai Hospital
CollaboratorOTHER
Vietnam Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, single center, ramdomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * Severe neuromuscular disease.

Design outcomes

Primary

MeasureTime frameDescription
Oxygenationat day 1, 2, 3, 4, 5, 6, 7PaO2/FiO2 will be evaluated via arterial blood gas analysis every day during the first week treatment.
Pulmonary Mechanicat day 1, 2, 3, 4, 5, 6, 7Static Compliance

Secondary

MeasureTime frameDescription
Length of mechanical ventilated daysup to 28 daysDays of received mechanical ventilation
Pneumothorax or barotraumaup to 28 daysnew-onset of pneumothorax and barotrauma
Ventilator free daysup to 28 daysVentilator free days
SOFAat day 1, 3, 7Sequential Organ Failure Assessment
Mortalityup to 2 monthsthe survival rate(survival/total) during hospital stay
Rescue therapiesup to 7 daysNeuromuscular blocker, prone postition, ECMO
Length of ICU stayup to 28 daysDays of ICU stay

Countries

Vietnam

Contacts

Primary ContactTrung Van Dinh, MD
dinhvantrung.ptgh@gmail.com(+84) 988519190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026