Acute Hypoxemic Respiratory FailureNCT06936618
EIT-Guided Ventilator Settings in AHRF
A study testing Electrical Impedance Tomography (EIT), Enlight 2100 in people with Acute Hypoxemic Respiratory Failure and Acute Respiratory Distress Syndrome (ARDS), run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Mechanical Power
- What is being tested?
- Electrical Impedance Tomography (EIT), Enlight 2100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteThailand
- Study dates
- 17 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital, Mahidol University
Bangkok, 10700
Ranistha Ratanarat, MD, Nephrology, Critical care, +66896685287, ranittha@gmail.com
Ranistha Ratanarat, MD, Nephrology, Critical care
About this study
Official title: Using Electrical Impedance Tomography-Guided Ventilator Settings to Reduce Mechanical Power in Acute Hypoxemic Respiratory Failure : An Exploratory Study
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.
Read the 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
- Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Mechanical Power, Ventilator Induced Lung Injury, Electrical Impedance Tomography (EIT)
- Being tested
- Electrical Impedance Tomography (EIT), Enlight 2100
- Keywords
- Acute Hypoxemic Respiratory Failure; Electrical Impedance Tomography; Mechanical Power, Ventilator-induced lung injury
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Tomography (EIT), Enlight 2100Device
Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics.
| Study group | Role | What they receive |
|---|---|---|
| EIT-guided PEEP titration | Experimental | Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics. Receives: Device: Electrical Impedance Tomography (EIT), Enlight 2100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mechanical Power
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)
Measured: ฺ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)
Secondary outcomes (14)
Change in PEEP level
Positive End-Expiratory Pressure (PEEP) level before and after EIT-guided ventilator adjustment.
Unit of Measure: cmH₂O
Measured: At baseline and then 2 hours, 12 hours, 24 hours after EIT-guided PEEP titration
Change in Respiratory Static Compliance
calculate static respiratory compliance (tidal volume/driving pressure) before and after EIT-guided PEEP titration Unit of Measure: mL/cmH₂O
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in Driving Pressure
calculate driving pressure (plateau pressure - PEEP) following EIT-guided PEEP titration.
Unit of Measure: cmH₂O
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in Plateau Pressure
measure plateau pressure before and after EIT-guided PEEP titration.
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in 4∆P + RR Index
Calculated value of 4 x Driving Pressure + Respiratory Rate before and after EIT-guided PEEP titration.
Unit of Measure: Joules per minute (J/min)
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in Elastic dynamic power
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)
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
change in elastic static power
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)
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in resistive power
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)
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in arterial oxygen tension (PaO₂)
Arterial oxygen tension (PaO₂) measured by arterial blood gas analysis before and after EIT-guided PEEP titration.
Unit of Measure: PaO₂: mmHg
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Ventilation distribution ratio
record anterior/posterior and right/left ventilation distribution from EIT before and after EIT-guided PEEP titration Unit of Measure: Percentage (%)
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Incidence of complication
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
Measured: Up to 24 hours after intervention
Change in arterial carbon dioxide tension (PaCO₂)
Carbon dioxide tension (PaCO₂) measured by arterial blood gas analysis before and after EIT-guided PEEP titration.
Unit of Measure: PaCO₂: mmHg
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in arterial pH
Arterial pH measured by arterial blood gas analysis before and after EIT-guided PEEP titration.
Unit of Measure: pH: unitless
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in PaO₂/FiO₂ ratio
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
Measured: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start17 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled patients will receive the intervention using EIT-guided PEEP titration. Outcomes such as mechanical power, lung mechanics, and gas exchange will be measured before and after the intervention in a single-arm, pre-post study design.
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranistha Ratanarat, Associated Professor, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936618
- Sponsor's protocol ID
- SI 962/2024
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electrical Impedance Tomography-Guided Ventilator Settings to Reduce Mechanical Power in Acute Hypoxemic Respiratory Failure : An Exploratory Study
- ClinicalTrials.gov ID
- NCT06936618
- Acronym / sponsor ID
- SI 962/2024
- Conditions
- Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Mechanical Power, Ventilator Induced Lung Injury, Electrical Impedance Tomography (EIT)
- Keywords
- Acute Hypoxemic Respiratory Failure; Electrical Impedance Tomography; Mechanical Power, Ventilator-induced lung injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients will receive the intervention using EIT-guided PEEP titration. Outcomes such as mechanical power, lung mechanics, and gas exchange will be measured before and after the intervention in a single-arm, pre-post study design.
| Arm | Type | Receives |
|---|---|---|
| EIT-guided PEEP titration | Experimental | Device: Electrical Impedance Tomography (EIT), Enlight 2100Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance Tomography (EIT), Enlight 2100Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics. | Device | EIT-guided PEEP titration |
Primary outcome
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)
14 secondary outcomes
Change in PEEP level
Time frame: At baseline and then 2 hours, 12 hours, 24 hours after EIT-guided PEEP titration
Change in Respiratory Static Compliance
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in Driving Pressure
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in Plateau Pressure
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in 4∆P + RR Index
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in Elastic dynamic power
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
change in elastic static power
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in resistive power
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in arterial oxygen tension (PaO₂)
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Ventilation distribution ratio
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Incidence of complication
Time frame: Up to 24 hours after intervention
Change in arterial carbon dioxide tension (PaCO₂)
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in arterial pH
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Change in PaO₂/FiO₂ ratio
Time frame: Baseline, 2 hours, 12 hours, and 24 hours after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ranistha Ratanarat, Associated Professor, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography (EIT), Enlight 2100 in people with Acute Hypoxemic Respiratory Failure and Acute Respiratory Distress Syndrome (ARDS), run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jitanong Sootlek, MD, PCCM (+66954164563, jitanong9651@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.