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Search / Trial NCT06936618

EIT-Guided Ventilator Settings in AHRF

Launched by MAHIDOL UNIVERSITY · Apr 17, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Acute Hypoxemic Respiratory Failure; Electrical Impedance Tomography; Mechanical Power, Ventilator Induced Lung Injury

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.

Locations

Bangkok, , Thailand

Patients applied

0 patients applied

Trial Officials

Ranistha Ratanarat, Associated Professor, MD

Principal Investigator

Siriraj Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported