HVNI Ambulation Feasibility Study

Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03885726

Enrollment

Registered

2019-03-22

Start date

2018-11-21

Completion date

2019-03-11

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Respiratory Insufficiency

Brief 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.

Detailed description

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.

Interventions

DEVICEPrecision Flow Plus

High velocity nasal insufflation

DEVICETreatment as Usual

Conventional therapy per institution

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Exercise Performance- Distance	Through study completion, an average of 1 day	Defined as the distance of patient ambulation
Exercise Performance- Duration	Through study completion, an average of 1 day	Defined as the duration of patient ambulation

Secondary

Measure	Time frame	Description
Patient Vital Signs-- Heart Rate [HR]	Through study completion, an average of 1 day	Heart rate in bpm
Patient Vital Signs-- Respiratory Rate [RR]	Through study completion, an average of 1 day	Respiratory rate in breaths per minute
Patient Vital Signs-- Arterial Oxygen Saturation	Through study completion, an average of 1 day	SpO2 measured as percentage of oxygen saturation (%).
Patient Vital Signs-- Rated Perceived Exertion (RPE)	Through study completion, an average of 1 day	Patient's subjective assessment of their exertion, rated as a modified Borg score on a scale from 0 to 10 . Higher scores indicate a worse outcome.
Patient Vital Signs-- Rated Perceived Dyspnea (RPD)	Through study completion, an average of 1 day	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.
Patient Recovery Interval	Through study completion, an average of 1 day	Defined as recovery time (return time to baseline rated perceived dyspnea).
Clinician Perception Score- Patient Tolerance and Comfort	Through study completion, an average of 1 day	Clinician's subjective assessment of the patient's comfort on and tolerance of the therapy, rated as units on a visual analog scale from 0 to 100. Lower values indicate a better outcome.
Clinician Perception Score- Frequency of Technical/Clinical Difficulties	Through study completion, an average of 1 day	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.
Clinician Perception Score- Simplicity of Set-up and Use	Through study completion, an average of 1 day	Clinician's subjective assessment of the the simplicity of setting up and using the equipment, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Clinician Perception Score- Support/Adjustment Required	Through study completion, an average of 1 day	Clinician's subjective assessment of the amount of support and adjustment required from the clinician during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Clinician Perception Score- Patient Response to Therapy	Through study completion, an average of 1 day	Clinician's subjective assessment of the patient's clinical response to the therapy, rated as units on a visual analog scale from 0 to 100. A lower score indicates a better outcome.
Patient Vital Signs - Blood Pressure	Through study completion, an average of 1 day	Patient blood pressure (systolic) measured in mmHg

Countries

United States

Participant flow

Recruitment details

Recruitment for this study took place in both an inpatient hospital setting and an outpatient medical clinic setting.

Pre-assignment details

Of the N=32 enrolled patients, only N=28 completed both study arms. An additional N=3 patients were excluded from study analysis, making the total number of patient data analyzed post-hoc N=25.

Participants by arm

Arm	Count
All Study Participants Crossover study design with the first intervention as Treatment as Usual - 6 minute walk test (TAU), followed by an adequate recovery period. The second intervention was High Velocity Nasal Insufflation - 6 minute walk test (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients.	25
Total	25

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Early discharge from hospital	3
Overall Study	Staffing issues/lost interest	1

Baseline characteristics

Characteristic	All Study Participants	—
Age, Continuous	66 years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	25 participants	—
Sex: Female, Male Female	12 Participants	—
Sex: Female, Male Male	13 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 25
other Total, other adverse events	0 / 25	0 / 25
serious Total, serious adverse events	0 / 25	0 / 25