NCT04512781

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Vapotherm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this study is to evaluate the ability of HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design, with which there are published clinical outcomes data. It is hypothesized that next generation nasal cannula designs (Prosoft and Unicorn) will be comparable at relieving patient dyspnea while on HVNI, when compared to the conventional (Legacy) cannula.

Conditions

• Dyspnea
• Hypercapnia
• Respiratory Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-06-07
• Completion: 2022-06-07
• First posted: 2020-08-14
• Last updated: 2024-02-23
• Results posted: 2024-02-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study