Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Conventional HVNI Device Design (Control) 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
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.
Other Names:
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| Experimental: New HVNI Device Design (Randomized) 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
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Patient Vital Signs -- Rated Perceived Dyspnea (RPD) [Through study completion, an average of 1.6 hours]
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] [Through study completion, an average of 1.6 hours]
Heart rate, measured in beats per minute (bpm)
- Patient Vital Signs - Respiratory Rate [RR] [Through study completion, an average of 1.6 hours]
Respiratory rate, measured in breaths per minute (brpm)
- Patient Vital Signs - Blood Pressure [BP] [Through study completion, an average of 1.6 hours]
Blood pressure (systolic) measured in mmHg
- Patient Vital Signs - Arterial Oxygen Saturation [SpO2] [Through study completion, an average of 1.6 hours]
SpO2 measured as percentage of oxygen saturation (%)
- Patient Vital Signs - Transcutaneous CO2 [TcPCO2] [Through study completion, an average of 1.6 hours]
TcPCO2, measured as percentage of CO2 (%)
Other Outcome Measures
- Clinician Perception Score - Frequency of Technical/Clinical Difficulties [Through study completion, an average of 1.6 hours]
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.
- Clinician Perception Score - Patient Comfort/Tolerance [Through study completion, an average of 1.6 hours]
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 Perception Score - Ease of Use [Through study completion, an average of 1.6 hours]
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.
- Clinician Perception Score - Monitoring & Support for Therapy [Through study completion, an average of 1.6 hours]
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.
- Clinician Perception Score - Expected/Perceived Patient Outcomes [Through study completion, an average of 1.6 hours]
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.
- Patient Perception Score - Relief of Symptoms [Through study completion, an average of 1.6 hours]
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.
- Patient Perception Score - Comfort/Tolerance of Therapy [Through study completion, an average of 1.6 hours]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult inpatients (18 years of age and older)
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Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
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Severe baseline hypercarbia/hypercapnia of 55 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas
Exclusion Criteria:
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Patient has unstable cardiovascular condition
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Significant unilateral or bilateral nasal occlusion
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Inability to provide informed consent
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Pregnancy
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Known contraindication to perform steps of the protocol
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Absence of spontaneous respiration or known contraindication to HVNI
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Inability to use HVNI therapy
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Agitation or uncooperativeness
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Determined by the clinician to be sufficiently unstable or unsuitable for this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | United States | 15240 |
Sponsors and Collaborators
- Vapotherm, Inc.
- VA Pittsburgh Healthcare System
Investigators
- Principal Investigator: Charles Atwood, VA Pittsburgh Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RP-VT2.02020001Sci