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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Insufficiency; Dyspnea; Hypercapnia
• Intervention / Treatment: Device: Conventional Precision Flow; Device: HVNI HVT2.0 Device

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).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional HVNI First, Then New HVNI Second (Randomized); The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.	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.; Other Names: Vapotherm Precision Flow; 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.; Other Names: HVNI Device Vapotherm V2.0
Experimental: New HVNI First, Then Conventional HVNI Second (Randomized); The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.	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.; Other Names: Vapotherm Precision Flow; 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.; Other Names: HVNI Device Vapotherm V2.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)	Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.	Through study completion, an average of 1.6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Vital Signs - Heart Rate [HR]	Heart rate, measured in beats per minute (bpm)	Through study completion, an average of 1.6 hours
Patient Vital Signs - Respiratory Rate [RR]	Respiratory rate, measured in breaths per minute (brpm)	Through study completion, an average of 1.6 hours
Patient Vital Signs - Blood Pressure [BP]	Blood pressure (systolic) measured in mmHg	Through study completion, an average of 1.6 hours
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	SpO2 measured as percentage of oxygen saturation (%)	Through study completion, an average of 1.6 hours
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	TcPCO2, measured as percentage of CO2 (%)	Through study completion, an average of 1.6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Perception Score - Frequency of Technical/Clinical Difficulties	Clinician's subjective assessment of the frequency of technical or clinical issues during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours
Clinician Perception Score - Patient Comfort/Tolerance	Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours
Clinician Perception Score - Ease of Use	Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours
Clinician Perception Score - Monitoring & Support for Therapy	Clinician's subjective assessment of the level of monitoring and support for therapy required during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours
Clinician Perception Score - Expected/Perceived Patient Outcomes	Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours
Patient Perception Score - Relief of Symptoms	Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours
Patient Perception Score - Comfort/Tolerance of Therapy	Patient's subjective assessment of their comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 1.6 hours

Collaborators and Investigators

• Sponsor: Vapotherm, Inc.
• Collaborators: VA Pittsburgh Healthcare System
• Investigators: Principal Investigator: Charles Atwood, VA Pittsburgh Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Dyspnea; Hypercapnia
• Other Study ID Numbers: RP-VT2.02020001Sci

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes