HVNI Ambulation Feasibility Study

The hypothesis is that HVNI therapy, when implemented in conjunction to ambulatory practices,
will be more effective than TAU to improve patient mobility by reducing the patient's
perceived dyspnea and exertion via maintaining oxygenation (reduced desaturation) and
supporting ventilation (reduced work of breathing [WOB]). The primary endpoint is exercise
performance, defined as the distance and duration of patient ambulation.

To provide a sample data set, The investigators will enroll up to 32 subjects to complete
this feasibility assessment, with a calculated sample size of N=26 plus a 20% failure rate.
This will provide sufficient initial data to inform the appropriate sample size of a
follow-on randomized study.

This will be a feasibility study, performed as a prospective, crossover controlled trial to
evaluate the potential patient improvement during ambulation while on HVNI relative to TAU.
Patients who fit the criteria for inclusion will perform ambulation for each study arm: the
control arm (TAU) followed by the test arm (HVNI). Control group will receive the site TAU
(not HVNI), and the test group will receive HVNI therapy. In both cases the clinical
management will otherwise remain unchanged based on the site SOC practices. The patient FiO2
and flow values will be recorded while on any supplemental oxygen. Subjects will wear
appropriate gear and, when applicable, have mobile carts to provide supplemental oxygen
therapy (e.g. HVNI VTU) during ambulation. If they meet criteria for intubation or are deemed
to need intubation by the critical care team, they will undergo prompt intubation and be
managed according to standard practice. After each of the study arms, the clinicians will
complete perception score assessments.

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