Measuring airway pressure to assess lung injury risk in ventilated patients
Effect of Different Measurements of End-inspiratory Airway Pressure on Driving Pressure and Mechanical Power in Mechanically Ventilated Patients: the P1-P2 Decay Study
This study tests if measuring airway pressure can help doctors better understand the risk of lung injury in critically ill patients on ventilators.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Padova Academic / other |
| Locations | 1 site (Padua) |
| Trial ID | NCT05991258 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between end-inspiratory airway pressure measurements and the risk of ventilator-induced lung injury (VILI) in patients undergoing mechanical ventilation. It focuses on critically ill patients with acute respiratory failure, utilizing specific respiratory variables such as plateau pressure and driving pressure to evaluate the risk of VILI. The study aims to improve patient outcomes by refining the assessment of ventilatory settings and their impact on lung injury. Participants will be monitored for their ability to tolerate specific pauses in ventilation to gather accurate pressure measurements.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are intubated or have a tracheostomy and are receiving controlled mechanical ventilation within 48 hours of ICU admission.
Not a fit: Patients who are not intubated or on mechanical ventilation, or those who cannot tolerate the required pauses in ventilation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing ventilator-induced lung injury in critically ill patients.
How similar studies have performed: Other studies have shown that measuring respiratory variables can help predict VILI risk, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age greater than 18 years old * Endotracheal intubation or tracheostomy * Controlled mechanical ventilation * Patient able to tolerate a 5-second end-inspiratory and end-expiratory pause with no hemodynamic or respiratory complications and pressure-time waveforms of sufficient quality for interpretation * Inclusion within 48 hours since ICU admission Exclusion criteria: - None (provided the inclusion criteria are satisfied)
Where this trial is running
Padua
- University Hospital of Padua — Padua, Italy (Recruiting)
Study contacts
- Principal investigator: Tommaso Pettenuzzo, MD — Institute of Anesthesiology and Intensive Care, Padua University Hospital
- Study coordinator: Tommaso Pettenuzzo, MD
- Email: tommaso.pettenuzzo@aopd.veneto.it
- Phone: 00390498213090
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.