Comparing helmet and facemask ventilation for respiratory failure
Physiological Effects of Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure
This study is testing whether using a helmet for breathing support is better than a facemask for people with severe breathing problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06210386 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of helmet noninvasive ventilation compared to facemask noninvasive ventilation in patients with acute hypoxemic respiratory failure. It employs a randomized crossover design to assess physiological effects, allowing for different ventilator settings to be tested. The goal is to determine if helmet ventilation can provide better outcomes by allowing higher positive end-expiratory pressure without air leaks while maintaining patient comfort.
Who should consider this trial
Good fit: Ideal candidates are patients experiencing acute hypoxemic respiratory failure with specific oxygenation criteria.
Not a fit: Patients with respiratory failure due to chronic pulmonary disease, cardiac failure, or fluid overload may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from acute hypoxemic respiratory failure.
How similar studies have performed: While the effectiveness of helmet ventilation is debated, this approach is being explored and may provide new insights into 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 or facemask noninvasive ventilation * 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
- Principal investigator: Domenico L. Grieco, MD — Fondazione Policlinico A. Gemelli IRCCS
- Study coordinator: Domenico L 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.