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HVNI Ambulation Feasibility Study

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ClinicalTrials.gov Identifier: NCT03885726
Recruitment Status : Completed
First Posted : March 22, 2019
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Knox Community Hospital
Riverside Regional Medical Center
Midwest Chest Consultants
Information provided by (Responsible Party):
Vapotherm, Inc.

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Dyspnea Device: Precision Flow Plus Device: Treatment as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment as Usual Device: Treatment as Usual
Conventional therapy per institution

Experimental: High Velocity Nasal Insufflation Device: Precision Flow Plus
High velocity nasal insufflation




Primary Outcome Measures :
  1. Exercise Performance- Distance [ Time Frame: Through study completion, an average of 1 day ]
    Defined as the distance of patient ambulation

  2. Exercise Performance- Duration [ Time Frame: Through study completion, an average of 1 day ]
    Defined as the duration of patient ambulation


Secondary Outcome Measures :
  1. Patient Recovery Interval [ Time Frame: Through study completion, an average of 1 day ]
    Defined as recovery time (return time to baseline rated perceived dyspnea).

  2. Patient Vital Signs - Blood Pressure [ Time Frame: Through study completion, an average of 1 day ]
    Patient blood pressure (systolic) measured in mmHg

  3. Patient Vital Signs-- Heart Rate [HR] [ Time Frame: Through study completion, an average of 1 day ]
    Heart rate in bpm

  4. Patient Vital Signs-- Respiratory Rate [RR] [ Time Frame: Through study completion, an average of 1 day ]
    Respiratory rate in breaths per minute

  5. Patient Vital Signs-- Arterial Oxygen Saturation [ Time Frame: Through study completion, an average of 1 day ]
    SpO2 measured as percentage of oxygen saturation (%).

  6. Patient Vital Signs-- Rated Perceived Exertion (RPE) [ Time Frame: 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.

  7. Patient Vital Signs-- Rated Perceived Dyspnea (RPD) [ Time Frame: 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.

  8. Clinician Perception Score- Patient Response to Therapy [ Time Frame: 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.

  9. Clinician Perception Score- Patient Tolerance and Comfort [ Time Frame: 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.

  10. Clinician Perception Score- Frequency of Technical/Clinical Difficulties [ Time Frame: 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.

  11. Clinician Perception Score- Simplicity of Set-up and Use [ Time Frame: 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.

  12. Clinician Perception Score- Support/Adjustment Required [ Time Frame: 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.

  13. Patient Vital Signs - Blood Pressure [ Time Frame: Through study completion, an average of 1 day ]
    Patient blood pressure (diastolic) measured in mmHg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885726


Locations
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United States, Missouri
Midwest Chest Consultants
Saint Charles, Missouri, United States, 63301
United States, Ohio
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
United States, Virginia
Riverside Regional Medical Center
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Vapotherm, Inc.
Knox Community Hospital
Riverside Regional Medical Center
Midwest Chest Consultants
Investigators
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Principal Investigator: Shailesh Patel, MD Knox Community Hospital
Principal Investigator: Thomas M Siler, MD Midwest Chest Consultants
Principal Investigator: Paragkumar Amin, MD Riverside Regional Medical Center
  Study Documents (Full-Text)

Documents provided by Vapotherm, Inc.:
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Responsible Party: Vapotherm, Inc.
ClinicalTrials.gov Identifier: NCT03885726    
Other Study ID Numbers: RP-VTPF2018001Sci
First Posted: March 22, 2019    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dyspnea
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases