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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Dyspnea; Hypercapnia
• Intervention / Treatment: Device: Control Cannula - Prosoft Cannula - Unicorn Cannula; Device: Control Cannula - Unicorn Cannula - Prosoft Cannula

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George C Dungan, II, M.Phil Med.; Phone Number: 192 (603) 658-0635; Email: gdungan@vtherm.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Baroness Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults, 18 years or older
• Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
• Severe baseline hypercarbia/hypercapnia of 50 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
• Vigorous physical activity should not be performed within 2 hours of testing
• 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 nasal cannula and 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: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula; During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters will be recorded. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.	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.
Experimental: Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula; During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters will be recorded. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.	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.

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.	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Vital Signs - Heart Rate [HR]	Heart Rate (HR) The number of beats per minute.	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Respiratory Rate [RR]	Respiratory rate, measured in breaths per minute (brpm)	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Blood Pressure [BP]	Blood pressure (systolic) measured in mmHg	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	SpO2 measured as percentage of oxygen saturation (%)	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	TcPCO2 measured as percentage of CO2 (%)	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 3 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 3 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 3 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 3 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 3 hours
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.	This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
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 3 hours

Collaborators and Investigators

• Sponsor: Vapotherm, Inc.
• Collaborators: VA Pittsburgh Healthcare System; Erlanger Baroness Hospital
• Investigators: Principal Investigator: Charles W Atwood, MD, FCCP, VA Pittsburgh Healthcare System; Principal Investigator: Jigme M Sethi, MD, FCCP, Erlanger Baroness Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 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-VTPF2018002Sci

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