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Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT04590014•Vapotherm, Inc.

Summary

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.

Detailed 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).

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

January 12, 2022

Primary Completion Date

July 15, 2022

Completion Date

July 15, 2022

Last Updated

March 20, 2024

Enrollment

ACTUAL participants

Conditions

DyspneaHypercapniaRespiratory Insufficiency

Interventions

Conventional Precision Flow

DEVICE

HVNI HVT2.0 Device

DEVICE

Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

NCT07468006

Respiratory Insufficiency in Children

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RECRUITINGNA

Platform of Randomized Adaptive Clinical Trials in Critical Illness

NCT05440851

Respiratory InsufficiencyExtracorporeal Membrane Oxygenation Complication+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

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