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Study was not needed from trial standpoint
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| Name | Class |
|---|---|
| VA Pittsburgh Healthcare System | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Precision Flow | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 1.6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Vital Signs - Heart Rate [HR] | Heart rate, measured in beats per minute (bpm) | Through study completion, an average of 1.6 hours |
| Patient Vital Signs - Respiratory Rate [RR] | Respiratory rate, measured in breaths per minute (brpm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Atwood | VA Pittsburgh Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional HVNI First New HVNI Second (Randomized) | Conventional First, New Second: 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. Next, 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. |
| FG001 | New HVNI First, Conventional HVNI Second (Randomized) | New First, Conventional Second: 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. Next, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional HVNI First New HVNI Second (Randomized) | Conventional First, New Second: 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. Next, 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. |
| 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 | 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. | Posted | Median | 95% Confidence Interval | Units on a scale | Through study completion, an average of 1.6 hours |
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For the duration of the study, from baseline to end of study, which was about 1.65 hours
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 | Precision Flow | Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Gerich | Vapotherm Inc | 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 | Jun 11, 2021 | Nov 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D006935 | Hypercapnia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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This trial is non-blinded by necessity, as there are distinct differences in size and appearance between the new and current HVNI device designs.
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| HVNI HVT2.0 Device | Device | 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. |
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| Through study completion, an average of 1.6 hours |
| Patient Vital Signs - Blood Pressure [BP] | Blood pressure (systolic) measured in mmHg | Through study completion, an average of 1.6 hours |
| Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | SpO2 measured as percentage of oxygen saturation (%) | Through study completion, an average of 1.6 hours |
| Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | TcPCO2, measured as percentage of CO2 (%) | Through study completion, an average of 1.6 hours |
| BG001 | New HVNI First, Conventional HVNI Second (Randomized) | New First, Conventional Second: 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. Next, 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Patient Vital Signs - Heart Rate [HR] | Heart rate, measured in beats per minute (bpm) | Posted | Median | 95% Confidence Interval | bpm | Through study completion, an average of 1.6 hours |
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| Secondary | Patient Vital Signs - Respiratory Rate [RR] | Respiratory rate, measured in breaths per minute (brpm) | Posted | Median | 95% Confidence Interval | breaths per min | Through study completion, an average of 1.6 hours |
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| Secondary | Patient Vital Signs - Blood Pressure [BP] | Blood pressure (systolic) measured in mmHg | Posted | Median | 95% Confidence Interval | mmHg | Through study completion, an average of 1.6 hours |
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| Secondary | Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | SpO2 measured as percentage of oxygen saturation (%) | Posted | Median | 95% Confidence Interval | % oxygen | Through study completion, an average of 1.6 hours |
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| Secondary | Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | TcPCO2, measured as percentage of CO2 (%) | Posted | Median | 95% Confidence Interval | % CO2 | Through study completion, an average of 1.6 hours |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | HVT 2.0 | Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Therapeutic Systolic |
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| Therapeutic Diastolic |
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