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

Primary Purpose

Dyspnea, Hypercapnia, Respiratory Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control HVNI Device
Test HVNI Device
Sponsored by
Vapotherm, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Pittsburgh Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional HVNI Device Design (Control)

New HVNI Device Design (Randomized)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Vital Signs - Heart Rate [HR]
Heart rate, measured in beats per minute (bpm)
Patient Vital Signs - Respiratory Rate [RR]
Respiratory rate, measured in breaths per minute (brpm)
Patient Vital Signs - Blood Pressure [BP]
Blood pressure (systolic) measured in mmHg
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
SpO2 measured as percentage of oxygen saturation (%)
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
TcPCO2, measured as percentage of CO2 (%)

Full Information

First Posted
October 5, 2020
Last Updated
February 10, 2023
Sponsor
Vapotherm, Inc.
Collaborators
VA Pittsburgh Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04590014
Brief Title
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
Official Title
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was not needed from trial standpoint
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vapotherm, Inc.
Collaborators
VA Pittsburgh Healthcare System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Hypercapnia, Respiratory Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
This trial is non-blinded by necessity, as there are distinct differences in size and appearance between the new and current HVNI device designs.
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional HVNI Device Design (Control)
Arm Type
Active Comparator
Arm Description
The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea.
Arm Title
New HVNI Device Design (Randomized)
Arm Type
Experimental
Arm Description
The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.
Intervention Type
Device
Intervention Name(s)
Control HVNI Device
Other Intervention Name(s)
Vapotherm Precision Flow
Intervention Description
During this session, 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.
Intervention Type
Device
Intervention Name(s)
Test HVNI Device
Other Intervention Name(s)
Vapotherm V2.0
Intervention Description
During this session, 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.
Primary Outcome Measure Information:
Title
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Secondary Outcome Measure Information:
Title
Patient Vital Signs - Heart Rate [HR]
Description
Heart rate, measured in beats per minute (bpm)
Time Frame
Through study completion, an average of 1.6 hours
Title
Patient Vital Signs - Respiratory Rate [RR]
Description
Respiratory rate, measured in breaths per minute (brpm)
Time Frame
Through study completion, an average of 1.6 hours
Title
Patient Vital Signs - Blood Pressure [BP]
Description
Blood pressure (systolic) measured in mmHg
Time Frame
Through study completion, an average of 1.6 hours
Title
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
Description
SpO2 measured as percentage of oxygen saturation (%)
Time Frame
Through study completion, an average of 1.6 hours
Title
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
Description
TcPCO2, measured as percentage of CO2 (%)
Time Frame
Through study completion, an average of 1.6 hours
Other Pre-specified Outcome Measures:
Title
Clinician Perception Score - Frequency of Technical/Clinical Difficulties
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Title
Clinician Perception Score - Patient Comfort/Tolerance
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Title
Clinician Perception Score - Ease of Use
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Title
Clinician Perception Score - Monitoring & Support for Therapy
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Title
Clinician Perception Score - Expected/Perceived Patient Outcomes
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Title
Patient Perception Score - Relief of Symptoms
Description
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.
Time Frame
Through study completion, an average of 1.6 hours
Title
Patient Perception Score - Comfort/Tolerance of Therapy
Description
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.
Time Frame
Through study completion, an average of 1.6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Atwood
Organizational Affiliation
VA Pittsburgh Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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