Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
1 other identifier
interventional
26
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2022
CompletedResults Posted
Study results publicly available
February 23, 2024
CompletedFebruary 23, 2024
February 1, 2024
1.7 years
August 6, 2020
November 20, 2023
February 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Secondary Outcomes (5)
Patient Vital Signs - Heart Rate [HR]
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Respiratory Rate [RR]
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Blood Pressure [BP]
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Other Outcomes (7)
Clinician Perception Score - Frequency of Technical/Clinical Difficulties
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Clinician Perception Score - Patient Comfort/Tolerance
Through study completion, an average of 3 hours
Clinician Perception Score - Ease of Use
Through study completion, an average of 3 hours
- +4 more other outcomes
Study Arms (2)
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula
EXPERIMENTALDuring this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters will be recorded. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.
Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula
EXPERIMENTALDuring this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters will be recorded. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.
Interventions
The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.
The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vapotherm, Inc.lead
- VA Pittsburgh Healthcare Systemcollaborator
- Erlanger Baroness Hospitalcollaborator
Study Sites (2)
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Erlanger Baroness Hospital
Chattanooga, Tennessee, 37403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small sample size and very specific scope of measuring RPD. Study was done during COVID pandemic. Screening efforts restricted to the ICU. Measurements were done with newer cannulas followed by legacy cannula. The study was non blinded. Patients may not have been aware of the difference between the legacy and the Prosoft cannula.
Results Point of Contact
- Title
- Amy Bergeski
- Organization
- Vapotherm
Study Officials
- PRINCIPAL INVESTIGATOR
Charles W Atwood, MD, FCCP
VA Pittsburgh Healthcare System
- PRINCIPAL INVESTIGATOR
Jigme M Sethi, MD, FCCP
Erlanger Baroness Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2020
First Posted
August 14, 2020
Study Start
October 1, 2020
Primary Completion
June 7, 2022
Study Completion
June 7, 2022
Last Updated
February 23, 2024
Results First Posted
February 23, 2024
Record last verified: 2024-02