Status:
COMPLETED
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
Lead Sponsor:
Vapotherm, Inc.
Collaborating Sponsors:
VA Pittsburgh Healthcare System
Erlanger Baroness Hospital
Conditions:
Dyspnea
Hypercapnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 conven...
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, w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04512781
Start Date
October 1 2020
End Date
June 7 2022
Last Update
February 23 2024
Active Locations (2)
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1
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
2
Erlanger Baroness Hospital
Chattanooga, Tennessee, United States, 37403