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HVNI vs NIPPV in Type 2 Respiratory Failure

ConditionsRespiratory FailureHypoxiaHypercapnia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH)

    Device

    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

    Device

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in PaCO2 levels at 30 and 60 minutes

Change in PaCO2 levels obtained on ABG results 30 minutes and 60 minutes after start of HVNI or NIPPV \[baseline ABG and ABGs at 30 minutes and 60 minutes will be performed\]

Time frame
30 minutes and 60 minutes

Secondary outcomes

1

Change in RR

Change in respiratory rate 30 minutes and 60 minutes after initiation of HVNI or NIPPV

Time frame
30 minutes and 60 minutes
2

Change in dypsnea level

Change in Modified Borg dyspnea scale 30 minutes and 60 minutes after initiation of HVNI or NIPPV

Time frame
30 minutes and 60 minutes
3

Proportion of treatment failure

Proportion of treatment failure (defined as need to convert to another oxygenation/ventilation therapy by clinical or ABG results, and need for intubation)

Time frame
Duration of therapy in emergency department, an average of 4 hours
4

Adverse events

Adverse events due to therapy rendered e.g., facial pain due to NIPPV mask application, vomiting, aspiration

Time frame
Duration of therapy in emergency department, an average of 4 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

Vapotherm, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: