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| Name | Class |
|---|---|
| VA Pittsburgh Healthcare System | FED |
| Erlanger Baroness Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Cannula - Prosoft Cannula - Unicorn Cannula | Device | 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. |
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Vital Signs - Heart Rate [HR] | Heart Rate (HR) The number of beats per minute. | 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles W Atwood, MD, FCCP | VA Pittsburgh Healthcare System | Principal Investigator |
| Jigme M Sethi, MD, FCCP | Erlanger Baroness Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States | ||
| Erlanger Baroness Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula | Conventional Legacy Cannula Design (Control) first for 40 min, then Prosoft Cannula for 40min - then Unicorn Cannula for 40 min") |
| FG001 | Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula | Conventional Legacy Cannula Design (Control) first for 40 min, then Unicorn Cannula for 40min - then Prosoft Cannula for 40 min") |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula | During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters were recorded. Patients were assigned to go on the Prosoft Cannula second. Physiologic and ventilation parameters were recorded. Patients were assigned to go on the Unicorn Cannula third. Physiologic and ventilation parameters were recorded |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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) |
|
Adverse Event reporting and collection was done over the duration of the trial, approximately 2 hours and 15 min.
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 | Legacy Cannula | During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Bergeski | Vapotherm | 570-351-6966 | Abergeski@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 10, 2021 | Nov 17, 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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|
| Control Cannula - Unicorn Cannula - Prosoft Cannula | Device | 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. |
|
Respiratory rate, measured in breaths per minute (brpm) |
| 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 | 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 (%) | 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 (%) | 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) |
| Clinician Perception Score - Patient Comfort/Tolerance | Clinician's subjective assessment of the patient's comfort and tolerance of therapy 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 3 hours |
| Clinician Perception Score - Ease of Use | Clinician's subjective assessment of the ease of use of therapy 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 3 hours |
| Clinician Perception Score - Monitoring & Support for Therapy | Clinician's subjective assessment of the level of monitoring and support for therapy required 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 3 hours |
| Clinician Perception Score - Expected/Perceived Patient Outcomes | Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Through study completion, an average of 3 hours |
| Patient Perception Score - Relief of Symptoms | Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Through study completion, an average of 3 hours |
| Patient Perception Score - Comfort/Tolerance of Therapy | Patient's subjective assessment of their comfort and tolerance of therapy 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 3 hours |
| Chattanooga |
| Tennessee |
| 37403 |
| United States |
| BG001 | Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula | During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters were recorded. Patients were assigned to go on the Unicorn Cannula second. Physiologic and ventilation parameters were recorded. Patients were assigned to go on the Prosoft Cannula third. Physiologic and ventilation parameters were recorded. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| height | There was a median calculated for all the participants, with a range of 1.7m to 1.80m | Median | Full Range | m |
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| Weight | a median for weight was calculated for all the participants, with a range of 82kg to 128kg | Median | Full Range | kg |
|
| OG002 | Unicorn Cannula | During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded. |
|
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| Secondary | Patient Vital Signs - Heart Rate [HR] | Heart Rate (HR) The number of beats per minute. | Posted | Median | 95% Confidence Interval | Beats per minute | 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 | Patient Vital Signs - Respiratory Rate [RR] | Respiratory rate, measured in breaths per minute (brpm) | Posted | Median | 95% Confidence Interval | BRPM | 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 | Patient Vital Signs - Blood Pressure [BP] | Blood pressure (systolic) measured in mmHg | Posted | Median | 95% Confidence Interval | mmHg | 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 | Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | SpO2 measured as percentage of oxygen saturation (%) | Posted | Median | 95% Confidence Interval | percentage of oxygen saturation | 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 | Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | TcPCO2 measured as percentage of CO2 (%) | Posted | Median | 95% Confidence Interval | percentage of CO2 | 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) |
|
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|
| Other Pre-specified | 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. | Not Posted | 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) | Participants |
| Other Pre-specified | Clinician Perception Score - Patient Comfort/Tolerance | Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Not Posted | Through study completion, an average of 3 hours | Participants |
| Other Pre-specified | Clinician Perception Score - Ease of Use | Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Not Posted | Through study completion, an average of 3 hours | Participants |
| Other Pre-specified | Clinician Perception Score - Monitoring & Support for Therapy | Clinician's subjective assessment of the level of monitoring and support for therapy required during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Not Posted | Through study completion, an average of 3 hours | Participants |
| Other Pre-specified | Clinician Perception Score - Expected/Perceived Patient Outcomes | Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Not Posted | Through study completion, an average of 3 hours | Participants |
| Other Pre-specified | Patient Perception Score - Relief of Symptoms | Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Not Posted | Through study completion, an average of 3 hours | Participants |
| Other Pre-specified | Patient Perception Score - Comfort/Tolerance of Therapy | Patient's subjective assessment of their comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome. | Not Posted | Through study completion, an average of 3 hours | Participants |
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Prosoft Cannula | During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Unicorn Cannula | During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
|