Comparing High Flow Nasal Cannula to Venturi Mask for Pneumonia-related Respiratory Failure
Open Randomized Controlled Clinical Trial Comparing Oxygen Therapy by High Flow Nasal Cannulae and by Venturi Mask in the Treatment of Acute Respiratory Failure Due to Severe Pneumonia (Hi Flow Oxygen vs Venturi Mask In Pneumonia)
This study is testing if using a High Flow Nasal Cannula for oxygen helps people with pneumonia-related breathing problems do better than using a standard Venturi mask.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Papa Giovanni XXIII Hospital Academic / other |
| Locations | 1 site (Bergamo) |
| Trial ID | NCT03515031 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of High Flow Nasal Cannula (HFNC) oxygenation compared to standard Venturi mask oxygen therapy in patients experiencing acute respiratory failure due to pneumonia. A total of 150 patients will be randomized into two groups: one receiving HFNC and the other receiving Venturi mask therapy. The primary focus is on clinical failure rates and the need for endotracheal intubation, while secondary outcomes include mortality rates, gas exchange improvement, and length of hospital stay. Both groups will receive appropriate antibiotic treatment as per established guidelines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute respiratory failure solely due to pneumonia and specific respiratory distress criteria.
Not a fit: Patients with respiratory failure caused by conditions other than pneumonia or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective oxygenation method for patients suffering from pneumonia-related respiratory failure.
How similar studies have performed: Previous studies have shown promising results with HFNC in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female of any ethnic group * age greater than or equal to 18 years; * respiratory rate (RR) at rest ≥ 20 breaths/minute or presence of respiratory distress (severe - dyspnea at rest or use of accessory respiratory muscles or paradox abdominal movement) PaO 2/ FiO 2 ≤250 during oxygen therapy with Venturi mask with FiO 2 50% administered for at least 60 minutes; * diagnosis of pneumonia as the unique cause of acute respiratory failure * informed consent obtained from the patient or the closest relative in case of patient's inability to give it. Exclusion Criteria: * other diagnoses (instead of pneumonia) as a cause of acute respiratory failure * unstable angina and acute myocardial infarction in place; * Acute respiratory acidosis with pH \<7.35 and PaCO 2 \> 45 mmHg; * systolic blood pressure \<90 mmHg unresponsive to fluids or with amines * severe arrhythmias; * epileptic seizures; * the degree of vigilance depending on the Kelly scale \> 3 (see Appendix II) * impaired swallowing, which increases the risk of pneumonia aspiration inability to protect airways * craniofacial trauma or burns * uncooperative patient * presence of open wound (skull, chest, abdomen) * respiratory arrest or need for intubation * ongoing pregnancy or suspected
Where this trial is running
Bergamo
- Vicky Rubini — Bergamo, Italy (Recruiting)
Study contacts
- Study coordinator: roberto cosentini, MD
- Email: r.cosentini@gmail.com
- Phone: +39 338 600 2601
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.