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

Vapotherm, Inc.5 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyspnea Hypercapnia Respiratory Insufficiency

Interventions

Conventional Precision FlowDEVICE

Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.

HVNI HVT2.0 DeviceDEVICE

Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Patient Vital Signs -- Rated Perceived Dyspnea (RPD)

Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.