DyspneaNCT04590014
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
A study testing Conventional Precision Flow and HVNI HVT2.0 Device in people with Dyspnea and Hypercapnia, run by Vapotherm, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Hypercapnia, Respiratory Insufficiency
- What is being tested?
- Conventional Precision Flow and HVNI HVT2.0 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Inability to use HVNI therapy
- Agitation or uncooperativeness
- Determined by the clinician to be sufficiently unstable or unsuitable for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
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.
Read the 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).
- Conditions
- Dyspnea, Hypercapnia, Respiratory Insufficiency
- Being tested
- Conventional Precision Flow, HVNI HVT2.0 Device
- Medical subject headings
- Dyspnea, Hypercapnia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Precision FlowDevice
Also called Vapotherm Precision Flow
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.
HVNI HVT2.0 DeviceDevice
Also called HVNI Device Vapotherm V2.0
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional HVNI First, Then New HVNI Second (Randomized) | Experimental | The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea. Receives: Device: Conventional Precision Flow; Device: HVNI HVT2.0 Device |
| New HVNI First, Then Conventional HVNI Second (Randomized) | Experimental | The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea. Receives: Device: Conventional Precision Flow; Device: HVNI HVT2.0 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1.6 hours
Secondary outcomes (5)
Patient Vital Signs - Heart Rate [HR]
Heart rate, measured in beats per minute (bpm)
Measured: Through study completion, an average of 1.6 hours
Patient Vital Signs - Respiratory Rate [RR]
Respiratory rate, measured in breaths per minute (brpm)
Measured: Through study completion, an average of 1.6 hours
Patient Vital Signs - Blood Pressure [BP]
Blood pressure (systolic) measured in mmHg
Measured: Through study completion, an average of 1.6 hours
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
SpO2 measured as percentage of oxygen saturation (%)
Measured: Through study completion, an average of 1.6 hours
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
TcPCO2, measured as percentage of CO2 (%)
Measured: Through study completion, an average of 1.6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Jan 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Why it stopped: Study was not needed from trial standpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vapotherm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Pittsburgh Healthcare System
- Responsible party
- Sponsor
- Investigators
- Charles Atwood, Principal investigator, VA Pittsburgh Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590014
- Sponsor's protocol ID
- RP-VT2.02020001Sci
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2020
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
- ClinicalTrials.gov ID
- NCT04590014
- Acronym / sponsor ID
- RP-VT2.02020001Sci
- Conditions
- Dyspnea, Hypercapnia, Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was not needed from trial standpoint
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vapotherm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VA Pittsburgh Healthcare System
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional HVNI First, Then New HVNI Second (Randomized) | Experimental | Device: Conventional Precision Flow, Device: HVNI HVT2.0 DeviceThe purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea. |
| New HVNI First, Then Conventional HVNI Second (Randomized) | Experimental | Device: Conventional Precision Flow, Device: HVNI HVT2.0 DeviceThe purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Precision FlowAlso: Vapotherm Precision FlowPatients 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. | Device | Conventional HVNI First, Then New HVNI Second (Randomized), New HVNI First, Then Conventional HVNI Second (Randomized) |
| HVNI HVT2.0 DeviceAlso: HVNI Device Vapotherm V2.0Patients 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. | Device | Conventional HVNI First, Then New HVNI Second (Randomized), New HVNI First, Then Conventional HVNI Second (Randomized) |
Primary outcome
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
Time frame: 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.
5 secondary outcomes
Patient Vital Signs - Heart Rate [HR]
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Respiratory Rate [RR]
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Blood Pressure [BP]
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
Time frame: Through study completion, an average of 1.6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Atwood principal investigator
VA Pittsburgh Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Precision Flow and HVNI HVT2.0 Device in people with Dyspnea and Hypercapnia, run by Vapotherm, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Vital Signs -- Rated Perceived Dyspnea (RPD) (time frame: Through study completion, an average of 1.6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.