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| Name | Class |
|---|---|
| Auburn University | OTHER |
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The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test. The study will include four study segments, corresponding to four different therapy settings.
HVT has been found to be a useful clinical tool for treatment of Type 1 and Type 2 respiratory failure (including hypercapnic respiratory failure), acute decompensated heart failure, and COVID respiratory complications. The overall objective of this prospective, pilot study is to evaluate whether HVT might enhance the decline of blood lactate concentrations following a high intensity exercise bout, in healthy volunteers. The hypothesis is that HVT, regardless of the oxygen concentration (i.e., FiO2), will reduce the work of breathing and increase the lactate clearance rate during exercise and recovery intervals. This pilot study could ignite further research providing HVT applications to high performing athletics and patients in an acute care setting requiring physical rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FiO2=100% with Flow=5LPM | Experimental | The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery. |
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| FiO2=21% with Flow=25-35LPM | Experimental | The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery. |
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| FiO2=100% with Flow=25-35LPM | Experimental | The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Velocity Therapy | Device | FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Lactate Change | The change in blood lactate starting from the exercise test throughout the recovery period | At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60). |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Change | The change in respiratory rate starting from the exercise test throughout the recovery period | Prior to the Wingate test (TR) and after at 1min (T1), 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Gladden | Auburn University | Principal Investigator |
| Michael Roberts | Auburn University | Principal Investigator |
| Max Michael | Auburn University | Principal Investigator |
| Nina Stute | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Auburn | Alabama | 36849 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Subjects will receive High Velocity Therapy. There will be four different flow settings and FIO2 for a total of four groups. Each participants will complete all four arms in randomized order. All 15 patients completed all 4 arms. FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FiO2=100% With Flow=5LPM |
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| FiO2=21% With Flow=25-35LPM |
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| FiO2=100% With Flow=25-35LPM |
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| FiO2=21% With Flow=5LPM |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Subject will receive High Velocity Therapy; four different flow settings and FIO2 for a total of four groups. FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-30LPM FiO2=100% with Flow=25-30LPM FiO2=21% with Flow=5LPM |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Blood Lactate Change | The change in blood lactate starting from the exercise test throughout the recovery period | Posted | Mean | Standard Deviation | mmol/L | At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60). |
|
The starting point was the exercise test, and AE data was collected throughout the recovery period for a total of 60 min. This was repeated for each arm, on different days.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | All Participants | Subject will receive High Velocity Therapy; four different flow settings and FIO2 for a total of four groups. FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Gerich | Vapotherm | 5854696753 | kgerich@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 | Sep 28, 2022 | Aug 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D000140 | Acidosis, Lactic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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|
| FiO2=21% with Flow=5LPM | Experimental | The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery. |
|
| Heart Rate Change |
The change in heart rate starting from the exercise test throughout the recovery period |
| Prior to the Wingate test (TR) and after 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
| SpO2 Change | The change in SpO2 starting from the exercise test throughout the recovery period. | Prior to the Wingate test (TR) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
| Systolic Blood Pressure Change | The change in systolic blood pressure starting from the exercise test throughout the recovery period. | Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
| Diastolic Blood Pressure Change | The change in diastolic blood pressure change starting from the exercise test throughout the recovery period. | Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
| Perceived Level of Exertion Change | The change in the subjects perceived level of exertion starting from after the exercise test throughout the recovery period. The scale will be 0-10; a lower score is a lower level of exhaustion, a higher score is a higher level of exhaustion. | Immediately after the Wingate test (T0) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG002 |
| FiO2=100% With Flow=5LPM |
High Velocity Therapy: Four different flow settings and FiO2 |
| OG003 | FiO2=100% With Flow=25-35LPM | High Velocity Therapy: Four different flow settings and FiO2 |
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| Secondary | Respiratory Rate Change | The change in respiratory rate starting from the exercise test throughout the recovery period | Subjects that had the data collected for the specified time point. | Posted | Mean | Standard Deviation | Breaths per min | Prior to the Wingate test (TR) and after at 1min (T1), 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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| Secondary | Heart Rate Change | The change in heart rate starting from the exercise test throughout the recovery period | Subjects that had this data collected for the specified time point. | Posted | Mean | Standard Deviation | Beats per min | Prior to the Wingate test (TR) and after 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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| Secondary | SpO2 Change | The change in SpO2 starting from the exercise test throughout the recovery period. | Subjects that had the data collected at that specified time point. | Posted | Mean | Standard Deviation | Percent oxygen | Prior to the Wingate test (TR) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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| Secondary | Systolic Blood Pressure Change | The change in systolic blood pressure starting from the exercise test throughout the recovery period. | Subjects that had this data collected for the specified time point. | Posted | Mean | Standard Deviation | mmHG | Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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| Secondary | Diastolic Blood Pressure Change | The change in diastolic blood pressure change starting from the exercise test throughout the recovery period. | Subjects that had this data collected for the specified time point. | Posted | Mean | Standard Deviation | mmHg | Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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| Secondary | Perceived Level of Exertion Change | The change in the subjects perceived level of exertion starting from after the exercise test throughout the recovery period. The scale will be 0-10; a lower score is a lower level of exhaustion, a higher score is a higher level of exhaustion. | Posted | Mean | Standard Deviation | units on a scale (0-10) | Immediately after the Wingate test (T0) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery. |
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| 15 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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