Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence

Stopped early · Not applicable

Conditions studied: Dyspnea, Hypercapnia, Respiratory Insufficiency

In brief

This study will evaluate the ability of a new High Velocity Nasal Insufflation \[HVNI\] device design to effect ventilation and related physiological responses relative to the current HVNI device design.

Key facts

Study ID

NCT04590014

Run by

Vapotherm, Inc.

People needed

5

Starts

2022-01-12

Expected to finish

2022-07-15

Last updated by the study team

2024-03-20

Who can join

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

You may qualify if…

• Adult inpatients (18 years of age and older)
• Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
• Severe baseline hypercarbia/hypercapnia of 55 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
• 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 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

Full record on ClinicalTrials.gov

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