Personalized noninvasive respiratory support for acute hypoxic respiratory failure
Physiological Effects of Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06202144
This study is testing a new personalized breathing support method for people with severe breathing problems to see if it works better than standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT06202144 on ClinicalTrials.gov |
What this trial studies
This study evaluates the physiological effects of a personalized noninvasive respiratory support approach based on individual inspiratory effort in patients with moderate-to-severe acute hypoxemic respiratory failure. Participants will undergo a decremental pressure-support trial using helmet noninvasive support, with various pressure settings applied sequentially while monitoring inspiratory effort through esophageal manometry. The personalized support will then be compared to conventionally set noninvasive ventilation (NIV) and continuous positive airway pressure (CPAP) in a randomized cross-over design.
Who should consider this trial
Good fit: Ideal candidates are patients experiencing acute hypoxemic respiratory failure with a PaO2/FiO2 ratio less than 200 mmHg.
Not a fit: Patients with respiratory failure due to chronic pulmonary disease exacerbations, cardiac failure, or fluid overload may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory support tailored to individual patient needs, potentially reducing lung injury and improving outcomes.
How similar studies have performed: While the approach of personalized noninvasive support is innovative, similar studies have shown varying success with noninvasive ventilation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg * PaCO2\<45 mmHg * Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload Exclusion Criteria: * Pregnancy * Contraindication to helmet support * Contraindication to esophageal manometry * Contraindication to electrical-impedance tomography monitoring * Recent surgery involving the abdomen or the thorax * Pneumothorax or documented barotrauma
Where this trial is running
Rome
- Fondazione Policlinico Universitaro A. Gemelli IRCCS — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Domenico Luca Grieco, MD
- Email: dlgrieco@outlook.it
- Phone: +393397681623
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: Acute Hypoxic Respiratory Failure