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

NCT04512781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-23

Study results available
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Summary

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.

Conditions

  • Dyspnea
  • Hypercapnia
  • Respiratory Insufficiency

Interventions

DEVICE

Control Cannula - Prosoft Cannula - Unicorn Cannula

The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.

DEVICE

Control Cannula - Unicorn Cannula - Prosoft Cannula

The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.

Sponsors & Collaborators

  • VA Pittsburgh Healthcare System

    collaborator FED

  • Erlanger Baroness Hospital

    collaborator OTHER_GOV

  • Vapotherm, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles W Atwood, MD, FCCP · VA Pittsburgh Healthcare System

  • Jigme M Sethi, MD, FCCP · Erlanger Baroness Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-07
Completion
2022-06-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512781 on ClinicalTrials.gov