DyspneaNCT04512781

Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs

A study of Dyspnea and Hypercapnia, run by Vapotherm, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyspnea, Hypercapnia, Respiratory Insufficiency
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: 1 Oct 2020to 7 Jun 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

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Erlanger Baroness Hospital
Chattanooga, Tennessee, 37403
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Read the 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, with which there are published clinical outcomes data. It is hypothesized that next generation nasal cannula designs (Prosoft and Unicorn) will be comparable at relieving patient dyspnea while on HVNI, when compared to the conventional (Legacy) cannula.

Conditions: Dyspnea, Hypercapnia, Respiratory Insufficiency
Being tested: Control Cannula - Prosoft Cannula - Unicorn Cannula, Control Cannula - Unicorn Cannula - Prosoft Cannula
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.

Control Cannula - Prosoft Cannula - Unicorn CannulaDevice
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.
Control Cannula - Unicorn Cannula - Prosoft CannulaDevice
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.

Study groups in NCT04512781
Study group	Role	What they receive
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula	Experimental	During 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. Receives: Device: Control Cannula - Prosoft Cannula - Unicorn Cannula
Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula	Experimental	During 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. Receives: Device: Control Cannula - Unicorn Cannula - Prosoft Cannula

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: 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]
Heart Rate (HR) The number of beats per minute.
Measured: 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]
Respiratory rate, measured in breaths per minute (brpm)
Measured: 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]
Blood pressure (systolic) measured in mmHg
Measured: 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]
SpO2 measured as percentage of oxygen saturation (%)
Measured: 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]
TcPCO2 measured as percentage of CO2 (%)
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20207 Jun 2022

First posted14 Aug 2020
Study start1 Oct 2020
Primary completion7 Jun 2022
Study completion7 Jun 2022

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: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04512781
Sponsor's protocol ID: RP-VTPF2018002Sci
Status last verified: Feb 2024
First submitted: 6 Aug 2020
Last updated: 23 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 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 Cannulae Designs
ClinicalTrials.gov ID: NCT04512781
Acronym / sponsor ID: RP-VTPF2018002Sci
Conditions: Dyspnea, Hypercapnia, Respiratory Insufficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Vapotherm, Inc.Industry (pharma, biotech, devices)
Collaborators: VA Pittsburgh Healthcare System, Erlanger Baroness Hospital
Study start: 1 Oct 2020 (actual)
Primary completion: 7 Jun 2022 (actual)
Study completion: 7 Jun 2022 (actual)
First posted: 14 Aug 2020 (actual)
Results: Posted 23 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula	Experimental	Device: Control Cannula - Prosoft Cannula - Unicorn CannulaDuring 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	Experimental	Device: Control Cannula - Unicorn Cannula - Prosoft CannulaDuring 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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

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
Control Cannula - Prosoft Cannula - Unicorn CannulaThe 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.	Device	Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula
Control Cannula - Unicorn Cannula - Prosoft CannulaThe 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.	Device	Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula

Primary outcome

Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
Time frame: 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'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: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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)

Results and safety

Results posted to the registry on 23 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula	15	15
Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula	11	11

Primary outcome: Patient Vital Signs -- Rated Perceived Dyspnea (RPD)

Time frame: 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). Median (95% Confidence Interval). Unit: units on a scale

Measure	Legacy Cannula n = 26	Prosoft Cannula n = 26	Unicorn Cannula n = 26
Value	3 (3 to 3)	2.5 (2 to 3)	2.5 (2 to 3)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event reporting and collection was done over the duration of the trial, approximately 2 hours and 15 min.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Legacy Cannula	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Prosoft Cannula	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Unicorn Cannula	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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 W Atwood, MD, FCCP principal investigator

VA Pittsburgh Healthcare System

Jigme M Sethi, MD, FCCP principal investigator

Erlanger Baroness Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Dyspnea and Hypercapnia, run by Vapotherm, Inc. at 2 sites 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 10 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: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 23 Feb 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: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04512781.

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 23 Feb 2024.