Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs

Completed · Not applicable

Conditions studied: Dyspnea, Hypercapnia, Respiratory Insufficiency

In brief

This study will evaluate the ability of High Velocity Nasal Insufflation \[HVNI\] next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design.

Key facts

Study ID

NCT04512781

Run by

Vapotherm, Inc.

People needed

26

Starts

2020-10-01

Expected to finish

2022-06-07

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults, 18 years or older
• Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
• Severe baseline hypercarbia/hypercapnia of 50 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas

You may not qualify if…

• Patient has unstable cardiovascular condition
• Significant unilateral or bilateral nasal occlusion
• Vigorous physical activity should not be performed within 2 hours of testing
• Inability to provide informed consent
• Pregnancy
• Known contraindication to perform steps of the protocol
• Absence of spontaneous respiration or known contraindication to HVNI
• Inability to use nasal cannula and HVNI therapy
• Agitation or uncooperativeness
• Determined by the clinician to be sufficiently unstable or unsuitable for this study

Where it is running

• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
• Erlanger Baroness Hospital — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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