Optimizing lung ventilation using pressure measurement and imaging techniques
Estimation of Optimal PEEP by Transpulmonary Pressure Measurement Following Recruitment Manoeuvre Under Computer Tomography and Electric Impedance Tomography Control
NA · Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged · NCT04174014
This study is testing a new way to help people with severe breathing problems by finding the best pressure settings for their lungs during ventilation to improve their oxygen levels without causing more harm.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged (other gov) |
| Drugs / interventions | radiation |
| Locations | 1 site (Szeged, Csongrád) |
| Trial ID | NCT04174014 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the management of hypoxic respiratory failure in patients with acute respiratory distress syndrome (ARDS) by optimizing positive end-expiratory pressure (PEEP) through transpulmonary pressure measurement and electric impedance tomography (EIT). It involves incrementing and decrementing PEEP levels while assessing alveolar recruitment using CT scans and continuous EIT monitoring. The goal is to determine the optimal pressure for lung recruitment, minimizing potential lung injury caused by mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates include intubated patients with moderate to severe hypoxic respiratory failure as defined by the ARDS Berlin criteria.
Not a fit: Patients under 18, pregnant women, or those with severe lung conditions or contraindications to specific procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance lung function and reduce complications in patients suffering from severe respiratory failure.
How similar studies have performed: While the use of PEEP optimization is common, the combination of transpulmonary pressure measurement and EIT for this specific purpose is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Orotracheally intubated patients ventilated in volume control mode with moderate and severe hypoxic respiratory failure according to the ARDS Berlin definition. * 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O (moderate) or PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O (sever) Exclusion Criteria: * age under 18 * pregnancy * pulmonectomy, lung resection in the past medical history * clinically end stage COPD * sever hemodynamic instability (vasopressor refractory shock) * sever bullous emphysema and/or spontaneous pneumothorax in the past medical history * chest drainage in situ due to pneumothorax and/or bronchopleural fistula * contraindication of the application of oesophageal balloon catheter (oesophageal ulcer, oesophageal perforation, oesophageal diverticulosis, oesophageal cancer, oesophageal varices, recent operation on oesophagus and/or stomach, sever coagulopathy)
Where this trial is running
Szeged, Csongrád
- University of Szeged, Department of Anesthesiology and Intensive Therapy — Szeged, Csongrád, Hungary (RECRUITING)
Study contacts
- Study coordinator: András Lovas, MD, PhD
- Email: lovas.andras@med.u-szeged.hu
- Phone: +3662545168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ARDS, Human