Comparing diaphragm activity during different mechanical ventilation methods
Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05990348
This study is testing how well two different types of breathing support help patients who are having trouble getting off mechanical ventilation by looking at their diaphragm and chest muscle activity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT05990348 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate diaphragm electrical activity and intercostal muscle thickening in patients experiencing difficult weaning from mechanical ventilation. It compares two ventilation modalities: Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support Ventilation (PSV). The study focuses on patients who have failed at least one weaning attempt and have been on mechanical ventilation for a minimum of 24 hours. By using non-invasive echography to assess muscle function, the study seeks to provide insights into the effectiveness of these ventilation strategies in preserving respiratory muscle function.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients who have failed at least one attempt to wean off mechanical ventilation.
Not a fit: Patients who are pregnant, obese, or have neuromuscular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the weaning process from mechanical ventilation, potentially reducing the duration of ventilation and associated complications.
How similar studies have performed: Previous studies have shown promising results with NAVA in reducing weaning failure, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients who have failed at least one weaning attempt * mechanical ventilation for at least 24 hours Exclusion Criteria: * Pregnancy * Obesity (Body Mass Index \> 35 kg/m2) * Contraindication to the insert of a nasogastric tube * Neuromuscular diseases
Where this trial is running
Rome
- Giorgia Spinazzola — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: giorgia GS spinazzola, md
- Email: giorgia.spinazzola@policlinicogemelli.it
- Phone: 0630154507
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: Respiratory Failure, Weaning Failure