Assessing lung injury risk in ventilated ARDS patients
Regional Assessment of the Risk of Lung Injury in Ventilated Patients With Similar Lung Load
This study is trying to see how different breathing settings on a ventilator might affect the risk of lung injury in patients with severe breathing problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital El Cruce Academic / other |
| Locations | 1 site (San Juan Bautista, Buenos Aires) |
| Trial ID | NCT06486259 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the risk of ventilator-induced lung injury (VILI) in patients with acute respiratory distress syndrome (ARDS) who are receiving controlled mechanical ventilation. It focuses on understanding how specific lung characteristics and ventilatory mechanics, such as tidal volume and pressure, contribute to the development of VILI. By measuring mechanical power, the study aims to provide insights into the energy applied to the lungs and its potential risks. The findings could help improve ventilation strategies and minimize lung injury in ARDS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with acute respiratory distress syndrome who require mechanical ventilation.
Not a fit: Patients with severe instability, certain esophageal pathologies, or those with a history of specific lung conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies that reduce the risk of lung injury in ARDS patients.
How similar studies have performed: While the approach of assessing mechanical power in relation to lung injury is gaining attention, this specific study's methodology is relatively novel and not extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ARDS patients \- Exclusion Criteria:Patients with any of the following criteria were excluded: * History of emphysema, asthma, pneumothorax, or active bronchopulmonary fistula. * Severe instability at the time of the study defined by at least one of the following indicators: SaO2 ≤ 90%, shock requiring \> 0.5 γ/kg/min of noradrenaline, complex arrhythmia, myocardial ischemia, intracranial hypertension refractory despite first-line measures. * Esophageal pathology contraindicating esophageal balloon placement (esophageal varices, stenosis, trauma or esophageal surgery, tumor) and/or hematemesis. * Severe coagulopathy (platelet count \<20,000/mm3 or INR \>4. * Inability to undergo computed tomography: morbid obesity (\>170 kg) or abdominal circumference \>200 cm. * Patients with do-not-resuscitate orders and pregnant women. * Participation in another research study in the last 30 days.
Where this trial is running
San Juan Bautista, Buenos Aires
- Hospital El Cruce — San Juan Bautista, Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Nestor Pistillo, MD — Hospital de Alta Complejidad en Red El Cruce Néstor C. Kirchner
- Study coordinator: Nestor Pistillo, MD
- Email: nestor.pistillo@hospitalelcruce.org
- Phone: 01134367989
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.