Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
Location status: Recruiting
Location contact
Ranistha Ratanarat, MD, Nephrology, Critical care
CONTACT
Ranistha Ratanarat, MD, Nephrology, Critical care
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06936618
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bangkok, 10700, Thailand
Location status: Recruiting
Ranistha Ratanarat, MD, Nephrology, Critical care
CONTACT
Ranistha Ratanarat, MD, Nephrology, Critical care
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics.
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)
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
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
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
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
measure plateau pressure before and after EIT-guided PEEP titration.
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)
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)
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)
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)
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
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 (%)
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
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
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
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
Contact information is provided by the study sponsor or research team.
Jitanong Sootlek, MD, PCCM
CONTACT
Ranistha Ratanarat, MD, Nephrology, Critical care
CONTACT
Mahidol University
Other
Using Electrical Impedance Tomography-Guided Ventilator Settings to Reduce Mechanical Power in Acute Hypoxemic Respiratory Failure : An Exploratory Study
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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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