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| Name | Class |
|---|---|
| Knox Community Hospital | OTHER |
| Riverside Medical Center | OTHER |
| Midwest Chest Consultants | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Active Comparator |
| |
| High Velocity Nasal Insufflation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Flow Plus | Device | High velocity nasal insufflation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Performance- Distance | Defined as the distance of patient ambulation | Through study completion, an average of 1 day |
| Exercise Performance- Duration | Defined as the duration of patient ambulation | Through study completion, an average of 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Recovery Interval | Defined as recovery time (return time to baseline rated perceived dyspnea). | Through study completion, an average of 1 day |
| Patient Vital Signs - Blood Pressure | Patient blood pressure (systolic) measured in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shailesh Patel, MD | Knox Community Hospital | Principal Investigator |
| Thomas M Siler, MD | Midwest Chest Consultants | Principal Investigator |
| Paragkumar Amin, MD | Riverside Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Chest Consultants | Saint Charles | Missouri | 63301 | United States | ||
| Knox Community Hospital |
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Of the N=32 enrolled patients, only N=28 completed both study arms. An additional N=3 patients were excluded from study analysis, making the total number of patient data analyzed post-hoc N=25.
Recruitment for this study took place in both an inpatient hospital setting and an outpatient medical clinic setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Performance- Distance | Defined as the distance of patient ambulation | N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc. | Posted | Median | Inter-Quartile Range | meters | Through study completion, an average of 1 day |
|
8 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual | Treatment as Usual: Conventional therapy per institution | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George C. Dungan, II | Vapotherm, Inc. | (267)347-3305 | gdungan@vtherm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2019 | Sep 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual |
| Device |
Conventional therapy per institution |
|
| Through study completion, an average of 1 day |
| Patient Vital Signs-- Heart Rate [HR] | Heart rate in bpm | Through study completion, an average of 1 day |
| Patient Vital Signs-- Respiratory Rate [RR] | Respiratory rate in breaths per minute | Through study completion, an average of 1 day |
| Patient Vital Signs-- Arterial Oxygen Saturation | SpO2 measured as percentage of oxygen saturation (%). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 1 day |
| Patient Vital Signs - Blood Pressure | Patient blood pressure (diastolic) measured in mmHg | Through study completion, an average of 1 day |
| Mount Vernon |
| Ohio |
| 43050 |
| United States |
| Riverside Regional Medical Center | Newport News | Virginia | 23601 | United States |
| years |
|
| Sex: Female, Male | Out of the N=28 patients who completed both arms of the study, N=3 were excluded post-hoc, making the total analysis population N=25. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc. | Number | participants |
|
| Treatment as Usual (Outpatient) |
Treatment as Usual: Conventional therapy per institution |
| OG003 | High Velocity Nasal Insufflation (Outpatient) | Precision Flow Plus: High Velocity Nasal Insufflation |
|
|
| Primary | Exercise Performance- Duration | Defined as the duration of patient ambulation | N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc. | Posted | Median | Inter-Quartile Range | seconds | Through study completion, an average of 1 day |
|
|
|
| Secondary | Patient Recovery Interval | Defined as recovery time (return time to baseline rated perceived dyspnea). | N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc. | Posted | Median | Inter-Quartile Range | seconds | Through study completion, an average of 1 day |
|
|
|
| Secondary | Patient Vital Signs - Blood Pressure | Patient blood pressure (systolic) measured in mmHg | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | mmHg | Through study completion, an average of 1 day |
|
|
|
| Secondary | Patient Vital Signs-- Heart Rate [HR] | Heart rate in bpm | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | beats per minute (bpm) | Through study completion, an average of 1 day |
|
|
|
| Secondary | Patient Vital Signs-- Respiratory Rate [RR] | Respiratory rate in breaths per minute | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | breaths per minute (brpm) | Through study completion, an average of 1 day |
|
|
|
| Secondary | Patient Vital Signs-- Arterial Oxygen Saturation | SpO2 measured as percentage of oxygen saturation (%). | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | percentage of oxygen saturation (%) | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | score on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | score on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | units on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | units on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | units on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of the N=32 patients enrolled in the study, N=28 completed all study arms. An additional N=3 were excluded from post-hoc analysis, making the final analysis N=25. | Posted | Median | Inter-Quartile Range | units on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | 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. | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | units on a scale | Through study completion, an average of 1 day |
|
|
|
| Secondary | Patient Vital Signs - Blood Pressure | Patient blood pressure (diastolic) measured in mmHg | Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25. | Posted | Median | Inter-Quartile Range | mmHg | Through study completion, an average of 1 day |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | High Velocity Nasal Insufflation | Precision Flow Plus: High velocity nasal insufflation | 0 | 25 | 0 | 25 | 0 | 25 |
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| D013568 | Pathological Conditions, Signs and Symptoms |