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

Vapotherm

Status: Terminated

Conditions: Dyspnea; Hypercapnia; Respiratory Insufficiency

Treatments: Device: HVNI HVT2.0 Device; Device: Conventional Precision Flow

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04590014

RP-VT2.02020001Sci

Details and patient eligibility

About

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.

Full description

The objective of this study is to evaluate the ability of a new HVNI device to improve ventilation, dyspnea, and related physiological responses relative to the conventional Precision Flow device design, with which there are published clinical outcomes data. It is hypothesized that the new HVNI device design (V2.0) will be comparable at relieving patient dyspnea when compared to the conventional HVNI device design (Precision Flow).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Conventional HVNI First, Then New HVNI Second (Randomized)

Experimental group

Description:

The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.

Treatment:

Device: Conventional Precision Flow

Device: HVNI HVT2.0 Device

New HVNI First, Then Conventional HVNI Second (Randomized)

Experimental group

Description:

The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.

Treatment:

Device: Conventional Precision Flow

Device: HVNI HVT2.0 Device