HVNI vs NIPPV in Type 2 Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorNational University Hospital, Singapore
About this trial
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).
Eligibility criteria
Qualifiers
adult patients aged 21 years and above, who require NIPPV for T2RF due to any cause in the Emergency Medicine Department of the National University Hospital
Disqualifiers
patients with "do-not-resuscitate" orders that include NO non-invasive ventilation use [patients with max NIV status will still be included]
clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes NIPPV or nasal cannula placement
vulnerable patient populations (e.g., pregnant women, prisoners)
patients who refused consent
Trial design
Treatments tested in this trial
- Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH)
- Respironics Vision V60
Treatment groups
84 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
National University Hospital, Singapore
Lead sponsor
Vapotherm, Inc.
Collaborator
Source ClinicalTrials.gov