18 and older, any sex, with Dyspnea or Hypercapnia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)Primary· Through study completion, an average of 1.6 hours
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.
Baseline
Group
Value
95% CI
Precision Flow
2.5
.98 – 4.02
HVT 2.0
3
.61 – 5.38
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
Group
Value
95% CI
Precision Flow
2.5
0.25 – 4.75
HVT 2.0
2
0.00 – 4.00
Patient Vital Signs - Heart Rate [HR]Secondary· Through study completion, an average of 1.6 hours
Heart rate, measured in beats per minute (bpm)
Baseline
Group
Value
95% CI
Precision Flow
81
78.24 – 83.76
HVT 2.0
76.5
72.32 – 80.68
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
Group
Value
95% CI
Precision Flow
81.5
79.98 – 83.02
HVT 2.0
79
75.47 – 82.53
Patient Vital Signs - Respiratory Rate [RR]Secondary· Through study completion, an average of 1.6 hours
Respiratory rate, measured in breaths per minute (brpm)
Baseline
Group
Value
95% CI
Precision Flow
19
11.42 – 26.58
HVT 2.0
17
12.89 – 21.11
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
Group
Value
95% CI
Precision Flow
16
8.94 – 23.06
HVT 2.0
12
6.49 – 17.51
Patient Vital Signs - Blood Pressure [BP]Secondary· Through study completion, an average of 1.6 hours
Blood pressure (systolic) measured in mmHg
Baseline Systolic
Group
Value
95% CI
Precision Flow
126.5
108.07 – 144.98
HVT 2.0
125
90.87 – 159.13
Baseline Diastolic
Group
Value
95% CI
Precision Flow
63
47.09 – 78.91
HVT 2.0
68.5
53.61 – 83.29
Therapeutic Systolic
Group
Value
95% CI
Precision Flow
129
111.70 – 146.30
HVT 2.0
136
104.46 – 166.54
Therapeutic Diastolic
Group
Value
95% CI
Precision Flow
73.5
55.15 – 91.85
HVT 2.0
68.5
57.84 – 79.16
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]Secondary· Through study completion, an average of 1.6 hours
SpO2 measured as percentage of oxygen saturation (%)
Baseline
Group
Value
95% CI
Precision Flow
96
94.00 – 98.00
HVT 2.0
95
88.85 – 101.15
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
Group
Value
95% CI
Precision Flow
94.5
93.58 – 95.42
HVT 2.0
94.5
90.71 – 98.29
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]Secondary· Through study completion, an average of 1.6 hours
TcPCO2, measured as percentage of CO2 (%)
Baseline
Group
Value
95% CI
Precision Flow
52.1
30.03 – 74.17
HVT 2.0
54.8
42.30 – 67.31
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
Group
Value
95% CI
Precision Flow
49.9
15.14 – 84.66
HVT 2.0
53.1
41.36 – 64.84
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vapotherm, Inc.
Last refreshed: 20 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04590014.