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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dyspnea, Hypercapnia, Respiratory Insufficiency

Intervention / Treatment
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* Device: Control Cannula
* Device: Test Cannula #1
* Device: Test Cannula #2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Legacy Cannula Design (Control)<br>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. | Device: Control Cannula<br>* The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea.<br>|
| Experimental: Cannula Design Test #1 (Randomized)<br>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. | Device: Test Cannula #1<br>* The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.<br>Device: Test Cannula #2<br>* 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.<br>|
| Experimental: Cannula Design Test #2 (Randomized)<br>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. | Device: Test Cannula #1<br>* The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.<br>Device: Test Cannula #2<br>* 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.<br>|

What is the study measuring?
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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 3 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 3 hours | 
| Patient Vital Signs - Respiratory Rate [RR] | Respiratory rate, measured in breaths per minute (brpm) | Through study completion, an average of 3 hours | 
| Patient Vital Signs - Blood Pressure [BP] | Blood pressure (systolic) measured in mmHg | Through study completion, an average of 3 hours | 
| Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | SpO2 measured as percentage of oxygen saturation (%) | Through study completion, an average of 3 hours | 
| Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | TcPCO2 measured as percentage of CO2 (%) | Through study completion, an average of 3 hours |