HVNI vs NIPPV in Type 2 Respiratory Failure

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).

NCT Number	NCT07065656
Lead Sponsor	National University Hospital, Singapore Collaborators: Vapotherm, Inc.
Conditions	Respiratory Failure, Hypoxia, Hypercapnia
Enrollment	84 participants
Start Date	2025-11-01
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-15