EIT-Guided Ventilator Settings in AHRF
Launched by MAHIDOL UNIVERSITY · Apr 17, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to adjust ventilator settings using a technique called Electrical Impedance Tomography (EIT) in patients who are experiencing severe breathing problems, known as acute hypoxemic respiratory failure (AHRF). The goal is to see if using EIT can help improve how the lungs work and reduce the risk of lung injury caused by the ventilator. The study will involve 17 patients at Siriraj Hospital who need invasive mechanical ventilation for at least 48 hours.
To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with AHRF within the last 48 hours. They should also be on mechanical ventilation within 24 hours of starting the study. However, certain conditions may prevent someone from participating, such as being pregnant, having a very high body weight, or having specific heart or lung issues. If someone joins the study, they can expect to have their ventilator settings adjusted based on the EIT measurements, and the team will monitor how well their lungs are functioning throughout the process.
Gender
ALL
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
About Mahidol University
Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkok, , Thailand
Patients applied
Trial Officials
Ranistha Ratanarat, Associated Professor, MD
Principal Investigator
Siriraj Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported