Respiratory InsufficiencyNCT03885726
HVNI Ambulation Feasibility Study
A study testing Precision Flow Plus and Treatment as Usual in people with Respiratory Insufficiency and Dyspnea, run by Vapotherm, Inc. at 3 sites in United States.
Trial summary
The pilot/feasibility study evaluates the ability of High Velocity Nasal Insufflation (HVNI) therapy to facilitate ambulation and mobilization in patients experiencing shortness of breath, as compared to simple oxygen therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Dyspnea
- What is being tested?
- Precision Flow Plus and Treatment as Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Nov 2018to 11 Mar 2019
- 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 over the age of 18 years
- Demonstrated respiratory distress upon mild to moderate exertion (e.g. dyspnea upon standing, walking, etc.)
- Candidate for clinical ambulation/mobilization
Who cannot join
- Hypoxemia at resting baseline: unable to maintain SpO2≥88% with supplemental oxygen
- Inability to provide informed consent
- Pregnancy
- Known contraindication to perform ambulation, per site SOC practices
- Inadequate respiratory drive or any known contraindications to HVNI
- Inability to use nasal cannula and HVNI therapy
- Agitation or uncooperativeness
- Determined by the attending clinician to be sufficiently unstable or unsuitable for this feasibility study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Knox Community Hospital
Mount Vernon, Ohio, 43050
Riverside Regional Medical Center
Newport News, Virginia, 23601
Midwest Chest Consultants
Saint Charles, Missouri, 63301
About this study
Official title: Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study
The pilot/feasibility study evaluates the ability of High Velocity Nasal Insufflation (HVNI) therapy to facilitate ambulation and mobilization in patients experiencing shortness of breath, as compared to simple oxygen therapy.
Read the detailed description
The hypothesis is that HVNI therapy, when implemented in conjunction to ambulatory practices, will be more effective than TAU to improve patient mobility by reducing the patient's perceived dyspnea and exertion via maintaining oxygenation (reduced desaturation) and supporting ventilation (reduced work of breathing [WOB]). The primary endpoint is exercise performance, defined as the distance and duration of patient ambulation.
To provide a sample data set, The investigators will enroll up to 32 subjects to complete this feasibility assessment, with a calculated sample size of N=26 plus a 20% failure rate. This will provide sufficient initial data to inform the appropriate sample size of a follow-on randomized study.
This will be a feasibility study, performed as a prospective, crossover controlled trial to evaluate the potential patient improvement during ambulation while on HVNI relative to TAU. Patients who fit the criteria for inclusion will perform ambulation for each study arm: the control arm (TAU) followed by the test arm (HVNI). Control group will receive the site TAU (not HVNI), and the test group will receive HVNI therapy. In both cases the clinical management will otherwise remain unchanged based on the site SOC practices. The patient FiO2 and flow values will be recorded while on any supplemental oxygen. Subjects will wear appropriate gear and, when applicable, have mobile carts to provide supplemental oxygen therapy (e.g. HVNI VTU) during ambulation. If they meet criteria for intubation or are deemed to need intubation by the critical care team, they will undergo prompt intubation and be managed according to standard practice. After each of the study arms, the clinicians will complete perception score assessments.
- Conditions
- Respiratory Insufficiency, Dyspnea
- Being tested
- Precision Flow Plus, Treatment as Usual
- Medical subject headings
- Respiratory Insufficiency, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Flow PlusDevice
High velocity nasal insufflation
Treatment as UsualDevice
Conventional therapy per institution
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Not described Receives: Device: Treatment as Usual |
| High Velocity Nasal Insufflation | Experimental | Not described Receives: Device: Precision Flow Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Performance- Distance
Defined as the distance of patient ambulation
Measured: Through study completion, an average of 1 day
Exercise Performance- Duration
Defined as the duration of patient ambulation
Measured: Through study completion, an average of 1 day
Secondary outcomes (13)
Patient Recovery Interval
Defined as recovery time (return time to baseline rated perceived dyspnea).
Measured: Through study completion, an average of 1 day
Patient Vital Signs - Blood Pressure
Patient blood pressure (systolic) measured in mmHg
Measured: Through study completion, an average of 1 day
Patient Vital Signs-- Heart Rate [HR]
Heart rate in bpm
Measured: Through study completion, an average of 1 day
Patient Vital Signs-- Respiratory Rate [RR]
Respiratory rate in breaths per minute
Measured: Through study completion, an average of 1 day
Patient Vital Signs-- Arterial Oxygen Saturation
SpO2 measured as percentage of oxygen saturation (%).
Measured: Through study completion, an average of 1 day
Patient Vital Signs-- Rated Perceived Exertion (RPE)
Patient's subjective assessment of their exertion, 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 day
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 day
Clinician Perception Score- Patient Response to Therapy
Clinician's subjective assessment of the patient's clinical response to the therapy, rated as units on a visual analog scale from 0 to 100. A lower score indicates a better outcome.
Measured: Through study completion, an average of 1 day
Clinician Perception Score- Patient Tolerance and Comfort
Clinician's subjective assessment of the patient's comfort on and tolerance of the therapy, rated as units on a visual analog scale from 0 to 100. Lower values indicate a better outcome.
Measured: Through study completion, an average of 1 day
Clinician Perception Score- Frequency of Technical/Clinical Difficulties
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.
Measured: Through study completion, an average of 1 day
Clinician Perception Score- Simplicity of Set-up and Use
Clinician's subjective assessment of the the simplicity of setting up and using the equipment, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Measured: Through study completion, an average of 1 day
Clinician Perception Score- Support/Adjustment Required
Clinician's subjective assessment of the amount of support and adjustment required from the clinician during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Measured: Through study completion, an average of 1 day
Patient Vital Signs - Blood Pressure
Patient blood pressure (diastolic) measured in mmHg
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start21 Nov 2018
- Primary completion28 Feb 2019
- Study completion11 Mar 2019
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 Respiratory InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vapotherm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Knox Community Hospital, Riverside Medical Center, Midwest Chest Consultants
- Responsible party
- Sponsor
- Investigators
- Shailesh Patel, MD, Principal investigator, Knox Community HospitalThomas M Siler, MD, Principal investigator, Midwest Chest ConsultantsParagkumar Amin, MD, Principal investigator, Riverside Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885726
- Sponsor's protocol ID
- RP-VTPF2018001Sci
- Status last verified
- Sep 2020
- First submitted
- 25 Feb 2019
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03885726
- Acronym / sponsor ID
- RP-VTPF2018001Sci
- Conditions
- Respiratory Insufficiency, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vapotherm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Knox Community Hospital, Riverside Medical Center, Midwest Chest Consultants
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pilot/feasibility study evaluates the ability of High Velocity Nasal Insufflation (HVNI) therapy to facilitate ambulation and mobilization in patients experiencing shortness of breath, as compared to simple oxygen therapy.
Detailed description
The hypothesis is that HVNI therapy, when implemented in conjunction to ambulatory practices, will be more effective than TAU to improve patient mobility by reducing the patient's perceived dyspnea and exertion via maintaining oxygenation (reduced desaturation) and supporting ventilation (reduced work of breathing [WOB]). The primary endpoint is exercise performance, defined as the distance and duration of patient ambulation.
To provide a sample data set, The investigators will enroll up to 32 subjects to complete this feasibility assessment, with a calculated sample size of N=26 plus a 20% failure rate. This will provide sufficient initial data to inform the appropriate sample size of a follow-on randomized study.
This will be a feasibility study, performed as a prospective, crossover controlled trial to evaluate the potential patient improvement during ambulation while on HVNI relative to TAU. Patients who fit the criteria for inclusion will perform ambulation for each study arm: the control arm (TAU) followed by the test arm (HVNI). Control group will receive the site TAU (not HVNI), and the test group will receive HVNI therapy. In both cases the clinical management will otherwise remain unchanged based on the site SOC practices. The patient FiO2 and flow values will be recorded while on any supplemental oxygen. Subjects will wear appropriate gear and, when applicable, have mobile carts to provide supplemental oxygen therapy (e.g. HVNI VTU) during ambulation. If they meet criteria for intubation or are deemed to need intubation by the critical care team, they will undergo prompt intubation and be managed according to standard practice. After each of the study arms, the clinicians will complete perception score assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Device: Treatment as Usual |
| High Velocity Nasal Insufflation | Experimental | Device: Precision Flow Plus |
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 over the age of 18 years
- Demonstrated respiratory distress upon mild to moderate exertion (e.g. dyspnea upon standing, walking, etc.)
- Candidate for clinical ambulation/mobilization
Key exclusion criteria (8 listed)
- Hypoxemia at resting baseline: unable to maintain SpO2≥88% with supplemental oxygen
- Inability to provide informed consent
- Pregnancy
- Known contraindication to perform ambulation, per site SOC practices
- Inadequate respiratory drive or any known contraindications to HVNI
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 |
|---|---|---|
| Precision Flow PlusHigh velocity nasal insufflation | Device | High Velocity Nasal Insufflation |
| Treatment as UsualConventional therapy per institution | Device | Treatment as Usual |
Primary outcome
Exercise Performance- Distance
Time frame: Through study completion, an average of 1 day
Defined as the distance of patient ambulation
Exercise Performance- Duration
Time frame: Through study completion, an average of 1 day
Defined as the duration of patient ambulation
13 secondary outcomes
Patient Recovery Interval
Time frame: Through study completion, an average of 1 day
Patient Vital Signs - Blood Pressure
Time frame: Through study completion, an average of 1 day
Patient Vital Signs-- Heart Rate [HR]
Time frame: Through study completion, an average of 1 day
Patient Vital Signs-- Respiratory Rate [RR]
Time frame: Through study completion, an average of 1 day
Patient Vital Signs-- Arterial Oxygen Saturation
Time frame: Through study completion, an average of 1 day
Patient Vital Signs-- Rated Perceived Exertion (RPE)
Time frame: Through study completion, an average of 1 day
Patient Vital Signs-- Rated Perceived Dyspnea (RPD)
Time frame: Through study completion, an average of 1 day
Clinician Perception Score- Patient Response to Therapy
Time frame: Through study completion, an average of 1 day
Clinician Perception Score- Patient Tolerance and Comfort
Time frame: Through study completion, an average of 1 day
Clinician Perception Score- Frequency of Technical/Clinical Difficulties
Time frame: Through study completion, an average of 1 day
Clinician Perception Score- Simplicity of Set-up and Use
Time frame: Through study completion, an average of 1 day
Clinician Perception Score- Support/Adjustment Required
Time frame: Through study completion, an average of 1 day
Patient Vital Signs - Blood Pressure
Time frame: Through study completion, an average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shailesh Patel, MD principal investigator
Knox Community Hospital
Thomas M Siler, MD principal investigator
Midwest Chest Consultants
Paragkumar Amin, MD principal investigator
Riverside Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Flow Plus and Treatment as Usual in people with Respiratory Insufficiency and Dyspnea, run by Vapotherm, Inc. at 3 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 8 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 19 Oct 2020). 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?
Exercise Performance- Distance (time frame: Through study completion, an average of 1 day). The study lists 2 primary outcomes in all. 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 19 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.