MedTrace Logo

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

NCT04590014 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-03-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Dyspnea
  • Hypercapnia
  • Respiratory Insufficiency

Interventions

DEVICE

Conventional Precision Flow

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.

DEVICE

HVNI HVT2.0 Device

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.

Sponsors & Collaborators

  • VA Pittsburgh Healthcare System

    collaborator FED

  • Vapotherm, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles Atwood · VA Pittsburgh Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2022-07-15
Completion
2022-07-15
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 NCT04590014 on ClinicalTrials.gov