An interventional study of Conventional Precision Flow and HVNI HVT2.0 Device in Dyspnea, Hypercapnia and Respiratory Insufficiency, sponsored by Vapotherm, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Vapotherm, Inc. · Not applicable, Interventional, and Treatment
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).
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 5 is below the median of 48 across 430 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →Vapotherm, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Conventional Precision Flow · Device: HVNI HVT2.0 Device
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.
Device: Conventional Precision Flow · Device: HVNI HVT2.0 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.
Also known as: Vapotherm Precision Flow
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.
Also known as: HVNI Device Vapotherm V2.0
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: Through study completion, an average of 1.6 hours
Patient Vital Signs - Heart Rate [HR]
Heart rate, measured in beats per minute (bpm)
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Respiratory Rate [RR]
Respiratory rate, measured in breaths per minute (brpm)
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Blood Pressure [BP]
Blood pressure (systolic) measured in mmHg
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
SpO2 measured as percentage of oxygen saturation (%)
Time frame: Through study completion, an average of 1.6 hours
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
TcPCO2, measured as percentage of CO2 (%)
Time frame: Through study completion, an average of 1.6 hours
| Milestone | Conventional HVNI First New HVNI Second (Randomized) | New HVNI First, Conventional HVNI Second (Randomized) |
|---|---|---|
| Started | 2 | 3 |
| Completed | 1 | 3 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Units on a scale | Precision Flow | HVT 2.0 |
|---|---|---|
| Baseline | 2.5 (.98 to 4.02) | 3 (.61 to 5.38) |
| Therapeutic Characterization once the HVNI settings are having a therapeutic effect. | 2.5 (0.25 to 4.75) | 2 (0.00 to 4.00) |
Heart rate, measured in beats per minute (bpm)
| bpm | Precision Flow | HVT 2.0 |
|---|---|---|
| Baseline | 81 (78.24 to 83.76) | 76.5 (72.32 to 80.68) |
| Therapeutic Characterization once the HVNI settings are having a therapeutic effect. | 81.5 (79.98 to 83.02) | 79 (75.47 to 82.53) |
Respiratory rate, measured in breaths per minute (brpm)
| breaths per min | Precision Flow | HVT 2.0 |
|---|---|---|
| Baseline | 19 (11.42 to 26.58) | 17 (12.89 to 21.11) |
| Therapeutic Characterization once the HVNI settings are having a therapeutic effect. | 16 (8.94 to 23.06) | 12 (6.49 to 17.51) |
Blood pressure (systolic) measured in mmHg
| mmHg | Precision Flow | HVT 2.0 |
|---|---|---|
| Baseline Systolic | 126.5 (108.07 to 144.98) | 125 (90.87 to 159.13) |
| Baseline Diastolic | 63 (47.09 to 78.91) | 68.5 (53.61 to 83.29) |
| Therapeutic Systolic | 129 (111.70 to 146.30) | 136 (104.46 to 166.54) |
| Therapeutic Diastolic | 73.5 (55.15 to 91.85) | 68.5 (57.84 to 79.16) |
SpO2 measured as percentage of oxygen saturation (%)
| % oxygen | Precision Flow | HVT 2.0 |
|---|---|---|
| Baseline | 96 (94.00 to 98.00) | 95 (88.85 to 101.15) |
| Therapeutic Characterization once the HVNI settings are having a therapeutic effect. | 94.5 (93.58 to 95.42) | 94.5 (90.71 to 98.29) |
TcPCO2, measured as percentage of CO2 (%)
| % CO2 | Precision Flow | HVT 2.0 |
|---|---|---|
| Baseline | 52.1 (30.03 to 74.17) | 54.8 (42.30 to 67.31) |
| Therapeutic Characterization once the HVNI settings are having a therapeutic effect. | 49.9 (15.14 to 84.66) | 53.1 (41.36 to 64.84) |
Collected over For the duration of the study, from baseline to end of study, which was about 1.65 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Precision Flow | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| HVT 2.0 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Conventional HVNI First New HVNI Second (Randomized) | New HVNI First, Conventional HVNI Second (Randomized) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 1 | 3 | 4 |
| Sex: Female, Male(Participants) | Conventional HVNI First New HVNI Second (Randomized) | New HVNI First, Conventional HVNI Second (Randomized) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Conventional HVNI First New HVNI Second (Randomized) | New HVNI First, Conventional HVNI Second (Randomized) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 3 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Vapotherm, Inc.