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HVNI vs NIPPV in Type 2 Respiratory Failure
Sponsor: National University Hospital, Singapore
Summary
The purpose of this study is to determine if high velocity nasal insufflation (HVNI) is comparable to non-invasive positive pressure ventilation (NIPPV) in treatment of emergency patients with acute respiratory acidosis. In our non-inferiority trial, we hypothesize that HVNI is inferior to NIPPV in reducing PaCO2 in type 2 respiratory failure (T2RF) due to any cause by a pre-specified non-inferiority margin of 4.3% decrease in PaCO2 levels after 30 minutes of treatment. The primary aim is to evaluate if HVNI is non-inferior to NIPPV in reducing PaCO2 levels in patients with T2RF from any cause. Eligible patients will be randomized to HVNI (intervention) or NIPPV (control).
Official title: Study of High-velocity Nasal Insufflation Versus Non-invasive Positive Pressure Ventilation for Emergency Type 2 Respiratory Failure: a Non-inferiority Randomized Controlled Trial (The SHINE Trial)
Key Details
Gender
All
Age Range
21 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-11-01
Completion Date
2027-12-31
Last Updated
2025-07-15
Healthy Volunteers
No
Conditions
Interventions
Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH)
Oxygen therapy will be given via the Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH) using a small-bore cannula, with a flow rate of up to 45 L/min, starting temperature of 37oC and FiO2 of up to 1.0.
Respironics Vision V60
Ventilation will be performed with the Respironics Vision V60 (Philips Healthcare, Murrysville, PA) using an oronasal mask of appropriate size, with FiO2 (up to 1.0), inspiratory (IPAP 12 to 20 cmH2O) and expiratory (EPAP 5 to 10 cm H2O) pressures titrated to alleviate patient's respiratory distress.