Dyspnea, Hypercapnia, Respiratory Insufficiency
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEControl Cannula - Prosoft Cannula - Unicorn Cannula
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.
DEVICEControl Cannula - Unicorn Cannula - Prosoft Cannula
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.
Sponsors
VA Pittsburgh Healthcare System
Erlanger Baroness Hospital
Vapotherm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, 18 years or older * Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea \[RPD\] (scale 0-10) of 3 or higher) * Severe baseline hypercarbia/hypercapnia of 50 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas
Exclusion criteria
* Patient has unstable cardiovascular condition * Significant unilateral or bilateral nasal occlusion * Vigorous physical activity should not be performed within 2 hours of testing * Inability to provide informed consent * Pregnancy * Known contraindication to perform steps of the protocol * Absence of spontaneous respiration or known contraindication to HVNI * Inability to use nasal cannula and HVNI therapy * Agitation or uncooperativeness * Determined by the clinician to be sufficiently unstable or unsuitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Vital Signs -- Rated Perceived Dyspnea (RPD) | 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'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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Vital Signs - Heart Rate [HR] | 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) | Heart Rate (HR) The number of beats per minute. |
| Patient Vital Signs - Respiratory Rate [RR] | 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) | Respiratory rate, measured in breaths per minute (brpm) |
| Patient Vital Signs - Blood Pressure [BP] | 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) | Blood pressure (systolic) measured in mmHg |
| Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | 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) | SpO2 measured as percentage of oxygen saturation (%) |
| Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | 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) | TcPCO2 measured as percentage of CO2 (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinician Perception Score - Frequency of Technical/Clinical Difficulties | 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'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. |
| Patient Perception Score - Comfort/Tolerance of Therapy | Through study completion, an average of 3 hours | 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. |
| Clinician Perception Score - Patient Comfort/Tolerance | Through study completion, an average of 3 hours | 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. |
| Clinician Perception Score - Ease of Use | Through study completion, an average of 3 hours | 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. |
| Clinician Perception Score - Monitoring & Support for Therapy | Through study completion, an average of 3 hours | 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. |
| Clinician Perception Score - Expected/Perceived Patient Outcomes | Through study completion, an average of 3 hours | 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. |
| Patient Perception Score - Relief of Symptoms | Through study completion, an average of 3 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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. | 11 |
| Total | 26 |
Baseline characteristics
| Characteristic | Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula | Total | Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 19 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 23 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| height | 1.78 m | 1.77 m | 1.72 m |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 7 Participants |
| Weight | 108.8 kg | 91 kg | 86.18 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
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.
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legacy Cannula | Patient Vital Signs -- Rated Perceived Dyspnea (RPD) | 3 units on a scale |
| Prosoft Cannula | Patient Vital Signs -- Rated Perceived Dyspnea (RPD) | 2.5 units on a scale |
| Unicorn Cannula | Patient Vital Signs -- Rated Perceived Dyspnea (RPD) | 2.5 units on a scale |
Secondary
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
SpO2 measured as percentage of oxygen saturation (%)
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legacy Cannula | Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | 95 percentage of oxygen saturation |
| Prosoft Cannula | Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | 95 percentage of oxygen saturation |
| Unicorn Cannula | Patient Vital Signs - Arterial Oxygen Saturation [SpO2] | 95 percentage of oxygen saturation |
Secondary
Patient Vital Signs - Blood Pressure [BP]
Blood pressure (systolic) measured in mmHg
Time frame: 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)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Legacy Cannula | Patient Vital Signs - Blood Pressure [BP] | Systolic | 126 mmHg |
| Legacy Cannula | Patient Vital Signs - Blood Pressure [BP] | Diastolic | 71 mmHg |
| Prosoft Cannula | Patient Vital Signs - Blood Pressure [BP] | Systolic | 126 mmHg |
| Prosoft Cannula | Patient Vital Signs - Blood Pressure [BP] | Diastolic | 71 mmHg |
| Unicorn Cannula | Patient Vital Signs - Blood Pressure [BP] | Systolic | 123 mmHg |
| Unicorn Cannula | Patient Vital Signs - Blood Pressure [BP] | Diastolic | 69 mmHg |
Secondary
Patient Vital Signs - Heart Rate [HR]
Heart Rate (HR) The number of beats per minute.
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legacy Cannula | Patient Vital Signs - Heart Rate [HR] | 78 Beats per minute |
| Prosoft Cannula | Patient Vital Signs - Heart Rate [HR] | 74 Beats per minute |
| Unicorn Cannula | Patient Vital Signs - Heart Rate [HR] | 76 Beats per minute |
Secondary
Patient Vital Signs - Respiratory Rate [RR]
Respiratory rate, measured in breaths per minute (brpm)
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legacy Cannula | Patient Vital Signs - Respiratory Rate [RR] | 16 BRPM |
| Prosoft Cannula | Patient Vital Signs - Respiratory Rate [RR] | 18 BRPM |
| Unicorn Cannula | Patient Vital Signs - Respiratory Rate [RR] | 16 BRPM |
Secondary
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
TcPCO2 measured as percentage of CO2 (%)
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Legacy Cannula | Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | 53.8 percentage of CO2 |
| Prosoft Cannula | Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | 50.7 percentage of CO2 |
| Unicorn Cannula | Patient Vital Signs - Transcutaneous CO2 [TcPCO2] | 50.3 percentage of CO2 |
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.
Time frame: Through study completion, an average of 3 hours
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.
Time frame: Through study completion, an average of 3 hours
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.
Time frame: 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)
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.
Time frame: Through study completion, an average of 3 hours
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.
Time frame: Through study completion, an average of 3 hours
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.
Time frame: Through study completion, an average of 3 hours
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.
Time frame: Through study completion, an average of 3 hours