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NCT Number: NCT06936618

EIT-Guided Ventilator Settings in AHRF

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Ranistha Ratanarat, MD, Nephrology, Critical care

CONTACT

[email protected]

+66896685287

Ranistha Ratanarat, MD, Nephrology, Critical care

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 or spinal cord trauma, recent thoracic surgery, etc.
  • High risk for PEEP titration
  • Hemodynamic instability defined as mean arterial pressure < 65 mmHg despite optimization 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 oxygen therapy, or previous lung function showing (FEV1 less than 20 ml/kg PBW, or FEV1/FVC less 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 radiographic x-ray evidence of any chronic over-inflation or chronic interstitial infiltration, or chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (unable to climb stairs or perform household duties, secondary polycythemia, severe pulmonary hypertension with mean pulmonary 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

Treatment and study plan

Electrical Impedance Tomography (EIT), Enlight 2100

Device

Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics.

Primary outcomes

  1. Change in Mechanical Power

    Time frame: ฺBaseline and 2 hours after EIT-guided ventilator adjustment and follow-up over 24 hours (baseline, 2 hours, 12 hours, and 24 hours after EIT-guided ventilator adjustment)

    Mechanical power (MP) will be calculated using Gattinoni's simplified formula. Simplified Gattinoni's formula: MP = 0.098 × respiratory rate × tidal volume × [peak inspiratory pressure - (plateau pressure - PEEP)/2] calculated mechanical power (measured in J/min) before and after using EIT-guided PEEP titration in patients with acute hypoxemic respiratory failure.

    Unit of Measure: Joules per minute (J/min)

Secondary outcomes

  1. Change in PEEP level

    Time frame: At baseline and then 2 hours, 12 hours, 24 hours after EIT-guided PEEP titration

    Positive End-Expiratory Pressure (PEEP) level before and after EIT-guided ventilator adjustment.

    Unit of Measure: cmH₂O

  2. Change in Respiratory Static Compliance

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    calculate static respiratory compliance (tidal volume/driving pressure) before and after EIT-guided PEEP titration Unit of Measure: mL/cmH₂O

  3. Change in Driving Pressure

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    calculate driving pressure (plateau pressure - PEEP) following EIT-guided PEEP titration.

    Unit of Measure: cmH₂O

  4. Change in Plateau Pressure

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    measure plateau pressure before and after EIT-guided PEEP titration.

  5. Change in 4∆P + RR Index

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    Calculated value of 4 x Driving Pressure + Respiratory Rate before and after EIT-guided PEEP titration.

    Unit of Measure: Joules per minute (J/min)

  6. Change in Elastic dynamic power

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    calculate elastic dynamic power formula : elastic dynamic power = 0.098 x respiratory rate x tidal volume x 0.5 x driving pressure before and following EIT-guided PEEP titration Unit of Measure: Joules per minute (J/min)

  7. change in elastic static power

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    calculated value of elastic static power = 0.098 x respiratory rate x tidal volume x PEEP before and after EIT-guided PEEP titration Unit of Measure: Joules per minute (J/min)

  8. Change in resistive power

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    calculated resistive power = 0.098 x respiratory rate x tidal volume x (peak inspiratory pressure - plateau pressure) before and after EIT-guided PEEP titration Unit of Measure: Joules per minute (J/min)

  9. Change in arterial oxygen tension (PaO₂)

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    Arterial oxygen tension (PaO₂) measured by arterial blood gas analysis before and after EIT-guided PEEP titration.

    Unit of Measure: PaO₂: mmHg

  10. Ventilation distribution ratio

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    record anterior/posterior and right/left ventilation distribution from EIT before and after EIT-guided PEEP titration Unit of Measure: Percentage (%)

  11. Incidence of complication

    Time frame: Up to 24 hours after intervention

    Number of patients experiencing adverse events related to EIT or ventilator adjustments, including pneumothorax, hemodynamic instability, or arrhythmia.

    Unit of Measure: Number of participants with event

  12. Change in arterial carbon dioxide tension (PaCO₂)

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    Carbon dioxide tension (PaCO₂) measured by arterial blood gas analysis before and after EIT-guided PEEP titration.

    Unit of Measure: PaCO₂: mmHg

  13. Change in arterial pH

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    Arterial pH measured by arterial blood gas analysis before and after EIT-guided PEEP titration.

    Unit of Measure: pH: unitless

  14. Change in PaO₂/FiO₂ ratio

    Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention

    PaO₂/FiO₂ ratio changes before and after EIT-guided PEEP titration. PaO₂/FiO₂ ratio will be calculated using PaO₂ from arterial blood gas and FiO₂ obtained from ventilator settings.

    Unit of Measure: PaO₂/FiO₂: mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Jitanong Sootlek, MD, PCCM

CONTACT

[email protected]

+66954164563

Ranistha Ratanarat, MD, Nephrology, Critical care

CONTACT

[email protected]

+66896685287

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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