EIT-Guided Ventilator Settings in AHRF

Last updated: April 22, 2025
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Treatment

Electrical Impedance Tomography (EIT), Enlight 2100

Clinical Study ID

NCT06936618
SI 962/2024
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Diagnosed with acute hypoxemic respiratory failure within 48 hours

  • Expected to require invasive mechanical ventilation ≥ 48 hours

  • On mechanical ventilation within 24 hours

  • Deep sedation and neuromuscular blockade

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Body mass index (BMI) > 40 kg/m2

  • Contraindications to using electrical impedance tomography, including

  • Presence of a pacemaker or automatic implantable cardioverter-defibrillator (AICD)

  • Inability to place the belt due to presence of surgical wounds dressing, thoracic orspinal cord trauma, recent thoracic surgery, etc.

  • High risk for PEEP titration

  • Hemodynamic instability defined as mean arterial pressure < 65 mmHg despiteoptimization of fluid status and/or use of vasopressors

  • Unstable cardiac arrhythmias

  • Presence of lung bullae greater than 2 cm in diameter, identified on chest X-ray

  • Presence of pneumothorax or pneumomediastinum

  • Right-sided heart failure or severe pulmonary hypertension

  • Neurologic conditions associated with a risk of intracranial hypertension

  • Use of extracorporeal membrane oxygenation (ECMO)

  • Severe chronic respiratory disease, defined as follows: requiring home oxygentherapy, or previous lung function showing (FEV1 less than 20 ml/kg PBW, or FEV1/FVCless than 50% predicted value), or chronic hypercapnia (PaCO2 greater than 45 mmHg)and/or chronic hypoxemia (PaO2 less than 55 mmHg) on FIO2 = 0.21, or radiographicx-ray evidence of any chronic over-inflation or chronic interstitial infiltration,or chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vasculardisease resulting in severe exercise restriction (unable to climb stairs or performhousehold duties, secondary polycythemia, severe pulmonary hypertension with meanpulmonary arterial pressure greater than 40 mmHg)

  • Decision to withhold life-sustaining treatment or palliative care.

  • Moribund status with an expected survival of less than 24 hours.

  • Refusal to provide informed consent

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: Electrical Impedance Tomography (EIT), Enlight 2100
Phase:
Study Start date:
December 17, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.