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

Not Applicable

Recruiting

• Conditions: Acute Respiratory Syndrome Distress; Positive End-Expiratory Pressure; Mechanical Ventilation; Electrical Impedance Tomography (EIT)

• Registration Number: NCT06733168
• Lead Sponsor: Vietnam Military Medical University

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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-15
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxygenation	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.
Pulmonary Mechanic	at day 1, 2, 3, 4, 5, 6, 7	Static Compliance

Secondary Outcome Measures

Name	Time	Method
Ventilator free days	up to 28 days	Ventilator free days
Length of ICU stay	up to 28 days	Days of ICU stay
Length of mechanical ventilated days	up to 28 days	Days of received mechanical ventilation
Pneumothorax or barotrauma	up to 28 days	new-onset of pneumothorax and barotrauma
Rescue therapies	up to 7 days	Neuromuscular blocker, prone postition, ECMO
SOFA	at day 1, 3, 7	Sequential Organ Failure Assessment
Mortality	up to 2 months	the survival rate(survival/total) during hospital stay

Trial Locations

Locations (1)

Intensive Care Center, Bach Mai Hospital; 🇻🇳 Hanoi, Vietnam