NCT04590014

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Vapotherm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dyspnea
• Hypercapnia
• Respiratory Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-12
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2020-10-19
• Last updated: 2024-03-20
• Results posted: 2024-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study