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

Primary Purpose

Dyspnea, Hypercapnia, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Cannula
Test Cannula #1
Test Cannula #2
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:

  • 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

Sites / Locations

  • VA Pittsburgh Healthcare System
  • Erlanger Baroness Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional Legacy Cannula Design (Control)

Cannula Design Test #1 (Randomized)

Cannula Design Test #2 (Randomized)

Arm Description

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.

During this session, patients will be placed on HVNI therapy with one of the next generation cannula designs. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.

During this session, patients will be placed on HVNI therapy with one of the next generation cannula designs. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.

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
August 6, 2020
Last Updated
February 9, 2023
Sponsor
Vapotherm, Inc.
Collaborators
VA Pittsburgh Healthcare System, Erlanger Baroness Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04512781
Brief Title
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
Official Title
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)

3. Sponsor/Collaborators

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

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 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.

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
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Legacy Cannula Design (Control)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cannula Design Test #1 (Randomized)
Arm Type
Experimental
Arm Description
During this session, patients will be placed on HVNI therapy with one of the next generation cannula designs. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.
Arm Title
Cannula Design Test #2 (Randomized)
Arm Type
Experimental
Arm Description
During this session, patients will be placed on HVNI therapy with one of the next generation cannula designs. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.
Intervention Type
Device
Intervention Name(s)
Control Cannula
Intervention Description
The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea.
Intervention Type
Device
Intervention Name(s)
Test Cannula #1
Intervention Description
The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.
Intervention Type
Device
Intervention Name(s)
Test Cannula #2
Intervention Description
The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design in providing targeted relief of dyspnea in hypercapnic adults.
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 3 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 3 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 3 hours
Title
Patient Vital Signs - Blood Pressure [BP]
Description
Blood pressure (systolic) measured in mmHg
Time Frame
Through study completion, an average of 3 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 3 hours
Title
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
Description
TcPCO2 measured as percentage of CO2 (%)
Time Frame
Through study completion, an average of 3 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 3 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. 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 3 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 3 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 3 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 3 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 3 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 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles W Atwood, MD, FCCP
Organizational Affiliation
VA Pittsburgh Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jigme M Sethi, MD, FCCP
Organizational Affiliation
Erlanger Baroness Hospital
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
Facility Name
Erlanger Baroness Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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