NCT03885726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

February 25, 2019

Results QC Date

September 2, 2020

Last Update Submit

September 23, 2020

Conditions

Respiratory InsufficiencyDyspnea

Outcome Measures

Primary Outcomes (2)

  • Exercise Performance- Distance

    Defined as the distance of patient ambulation

    Through study completion, an average of 1 day

  • Exercise Performance- Duration

    Defined as the duration of patient ambulation

    Through study completion, an average of 1 day

Secondary Outcomes (13)

  • Patient Recovery Interval

    Through study completion, an average of 1 day

  • Patient Vital Signs - Blood Pressure

    Through study completion, an average of 1 day

  • Patient Vital Signs-- Heart Rate [HR]

    Through study completion, an average of 1 day

  • Patient Vital Signs-- Respiratory Rate [RR]

    Through study completion, an average of 1 day

  • Patient Vital Signs-- Arterial Oxygen Saturation

    Through study completion, an average of 1 day

  • +8 more secondary outcomes

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR
Device: Treatment as Usual

High Velocity Nasal Insufflation

EXPERIMENTAL
Device: Precision Flow Plus

Interventions

Precision Flow PlusDEVICE

High velocity nasal insufflation

High Velocity Nasal Insufflation
Treatment as UsualDEVICE

Conventional therapy per institution

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Midwest Chest Consultants

Saint Charles, Missouri, 63301, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Riverside Regional Medical Center

Newport News, Virginia, 23601, United States

Location

MeSH Terms

Conditions

Respiratory InsufficiencyDyspnea

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
George C. Dungan, II
Organization
Vapotherm, Inc.
gdungan@vtherm.com
(267)347-3305

Study Officials

  • Shailesh Patel, MD

    Knox Community Hospital

    PRINCIPAL INVESTIGATOR

  • Thomas M Siler, MD

    Midwest Chest Consultants

    PRINCIPAL INVESTIGATOR

  • Paragkumar Amin, MD

    Riverside Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 22, 2019

Study Start

November 21, 2018

Primary Completion

February 28, 2019

Study Completion

March 11, 2019

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)