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RecruitingNCT06936618

EIT-Guided Ventilator Settings in AHRF

Using Electrical Impedance Tomography-Guided Ventilator Settings to Reduce Mechanical Power in Acute Hypoxemic Respiratory Failure : An Exploratory Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
17 (estimated)
Sponsor
Mahidol University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This exploratory study aims to investigate the effect of Electrical Impedance Tomography (EIT)-guided ventilator settings on mechanical power in patients with acute hypoxemic respiratory failure (AHRF), including both ARDS and non-ARDS conditions. Mechanical power, a key factor associated with ventilator-induced lung injury (VILI), will be measured before and after EIT-guided PEEP titration. The study will evaluate feasibility and changes in lung mechanics, gas exchange, and EIT parameters. A total of 17 patients requiring invasive mechanical ventilation will be enrolled at Siriraj Hospital, Mahidol University.

Detailed description

This exploratory study investigates the effect of Electrical Impedance Tomography (EIT)-guided PEEP titration on mechanical power in patients with acute hypoxemic respiratory failure (AHRF), including both ARDS and non-ARDS conditions such as severe pneumonia and pulmonary edema. Mechanical power represents the energy transferred from the ventilator to the respiratory system per unit time and has been associated with the development of ventilator-induced lung injury (VILI). Patients who meet the inclusion criteria will undergo a standardized EIT-guided PEEP titration protocol using the Enlight 2100 EIT device. Optimal PEEP is defined as the PEEP level that minimizes both alveolar overdistension and collapse based on real-time EIT measurements. Mechanical power and other ventilatory parameters (lung compliance, plateau pressure, driving pressure, 4∆P x RR index, and gas exchange) will be assessed before and after PEEP titration at predefined time points (baseline, 2, 12, and 24 hours). The study also evaluates the regional ventilation distribution ratios, as well as safety outcomes including hemodynamic instability, arrhythmias, and pneumothorax. Patients will be followed for up to 28 days to record duration of mechanical ventilation, ICU stay, and 28-day mortality. This study aims to assess the feasibility and physiological benefits of personalized ventilator settings using EIT in critically ill patients with AHRF and to generate preliminary data for future interventional studies.

Conditions

Interventions

TypeNameDescription
DEVICEElectrical Impedance Tomography (EIT), Enlight 2100Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics.

Timeline

Start date
2024-12-17
Primary completion
2026-10-01
Completion
2026-12-01
First posted
2025-04-20
Last updated
2025-04-27

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT06936618. Inclusion in this directory is not an endorsement.