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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Dyspnea, Hypercapnia, Respiratory Insufficiency

Intervention / Treatment
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* Device: Control HVNI Device
* Device: Test HVNI Device


Participation Criteria
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Eligibility Criteria
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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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional HVNI Device Design (Control)<br>The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. | Device: Control HVNI Device<br>* 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.<br>* Other names: Vapotherm Precision Flow;|
| Experimental: New HVNI Device Design (Randomized)<br>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: Test HVNI Device<br>* 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.<br>* Other names: Vapotherm V2.0;|

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 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 |