Status:
COMPLETED
Physiology of Helmet vs. Facemask Noninvasive Ventilation
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Put...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06210386
Start Date
January 19 2024
End Date
September 15 2025
Last Update
September 30 2025
Active Locations (1)
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1
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy