Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06936618
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EIT-Guided Ventilator Settings in AHRF
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Using Electrical Impedance Tomography-Guided Ventilator Settings to Reduce Mechanical Power in Acute Hypoxemic Respiratory Failure : An Exploratory Study
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: