| NCT ID | NCT06936618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2024-12-17 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ranistha Ratanarat, Associated Professor, MD
PRINCIPAL INVESTIGATOR
Siriraj Hospital
Frequently Asked Questions
Who can join the NCT06936618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936618 currently recruiting?
Yes, NCT06936618 is actively recruiting participants. Contact the research team at jitanong9651@gmail.com for enrollment information.
Where is the NCT06936618 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT06936618 clinical trial?
NCT06936618 is sponsored by Mahidol University. The principal investigator is Ranistha Ratanarat, Associated Professor, MD at Siriraj Hospital. The trial plans to enroll 17 participants.