N/A
Completed N=32
HVNI Ambulation Feasibility Study
Respiratory Insufficiency · Dyspnea
Source: ClinicalTrials.gov NCT03885726 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Exercise Performance- Distance — 78.8; 88.6; 182.9; 165.2 meters
Summary
The pilot/feasibility study evaluates the ability of High Velocity Nasal Insufflation (HVNI) therapy to facilitate ambulation and mobilization in patients experiencing shortness of breath, as compared to simple oxygen therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Performance- Distance |
78.8; 88.6; 182.9; 165.2 | — |
| PRIMARY Exercise Performance- Duration |
211.5; 229.5; 307; 250 | — |
| SECONDARY Patient Recovery Interval |
283.5; 191.5; 239; 245 | — |
| SECONDARY Patient Vital Signs - Blood Pressure |
2; 2; 18.5; 18.5 | — |
| SECONDARY Patient Vital Signs-- Heart Rate [HR] |
101; 94; 81; 79 | — |
| SECONDARY Patient Vital Signs-- Respiratory Rate [RR] |
20; 18; 20; 20 | — |
| SECONDARY Patient Vital Signs-- Arterial Oxygen Saturation |
95; 95; 95; 95 | — |
| SECONDARY Patient Vital Signs-- Rated Perceived Exertion (RPE) |
1.5; 0.5; 0; 0.5 | — |
| SECONDARY Patient Vital Signs-- Rated Perceived Dyspnea (RPD) |
0.5; 0.75; 0; 0 | — |
| SECONDARY Clinician Perception Score- Patient Response to Therapy |
44.5; 8.25; 9; 37.5 | — |
| SECONDARY Clinician Perception Score- Patient Tolerance and Comfort |
33.8; 4; 1; 19 | — |
| SECONDARY Clinician Perception Score- Frequency of Technical/Clinical Difficulties |
1.5; 1.5; 1; 3 | — |
| SECONDARY Clinician Perception Score- Simplicity of Set-up and Use |
1; 1.5; 1; 2 | — |
| SECONDARY Clinician Perception Score- Support/Adjustment Required |
2; 2; 18.5; 18.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adults over the age of 18 years
- Demonstrated respiratory distress upon mild to moderate exertion (e.g. dyspnea upon standing, walking, etc.)
- Candidate for clinical ambulation/mobilization
Exclusion Criteria
- Hypoxemia at resting baseline: unable to maintain SpO2≥88% with supplemental oxygen
- Inability to provide informed consent
- Pregnancy
- Known contraindication to perform ambulation, per site SOC practices
- Inadequate respiratory drive or any known contraindications to HVNI
- Inability to use nasal cannula and HVNI therapy
- Agitation or uncooperativeness
- Determined by the attending clinician to be sufficiently unstable or unsuitable for this feasibility study
Data sourced from ClinicalTrials.gov (NCT03885726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.