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HVNI vs NIPPV in Type 2 Respiratory Failure

NCT07065656 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-07-15

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Vapotherm, Inc.

    collaborator INDUSTRY

  • National University Hospital, Singapore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-06-30
Completion
2027-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07065656 on ClinicalTrials.gov