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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.

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE March 22, 2019
Results First Submitted Date  ICMJE September 2, 2020
Results First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE November 21, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Exercise Performance- Distance [ Time Frame: Through study completion, an average of 1 day ]
    Defined as the distance of patient ambulation
  • Exercise Performance- Duration [ Time Frame: Through study completion, an average of 1 day ]
    Defined as the duration of patient ambulation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • Patient Recovery Interval [ Time Frame: Through study completion, an average of 1 day ]
    Defined as recovery time (return time to baseline rated perceived dyspnea).
  • Patient Vital Signs - Blood Pressure [ Time Frame: Through study completion, an average of 1 day ]
    Patient blood pressure (systolic) measured in mmHg
  • Patient Vital Signs-- Heart Rate [HR] [ Time Frame: Through study completion, an average of 1 day ]
    Heart rate in bpm
  • Patient Vital Signs-- Respiratory Rate [RR] [ Time Frame: Through study completion, an average of 1 day ]
    Respiratory rate in breaths per minute
  • Patient Vital Signs-- Arterial Oxygen Saturation [ Time Frame: Through study completion, an average of 1 day ]
    SpO2 measured as percentage of oxygen saturation (%).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Patient Vital Signs - Blood Pressure [ Time Frame: Through study completion, an average of 1 day ]
    Patient blood pressure (diastolic) measured in mmHg
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Patient Recovery Interval [ Time Frame: Through study completion, an average of 1 day ]
    Defined as recovery time (return time to baseline rated perceived dyspnea).
  • Patient Vital Signs - Blood Pressure [ Time Frame: Through study completion, an average of 1 day ]
    Blood pressure (systolic and diastolic) in mmHg
  • Patient Vital Signs-- Heart Rate [HR] [ Time Frame: Through study completion, an average of 1 day ]
    Heart rate in bpm
  • Patient Vital Signs-- Respiratory Rate [RR] [ Time Frame: Through study completion, an average of 1 day ]
    Respiratory rate in breaths per minute
  • Patient Vital Signs-- Arterial Oxygen Saturation [ Time Frame: Through study completion, an average of 1 day ]
    SpO2 in %
  • 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 on a modified BORG scale from 0 (nothing at all) to 10 (maximal exertion)
  • 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 on a modified BORG scale from 0 (nothing at all) to 10 (maximal dyspnea)
  • 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 on a scale. The scale is presented as a 100 mm line where one side is labeled "Excellent" and the other is labeled "Insufficient." Clinicians are asked to indicate with an X where on the line they would rate their assessment. The line is then measured; scores are recorded as how many mm on the line they are. A score of 0 is excellent and 100 is insufficient.
  • 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 on a scale. The scale is presented as a 100 mm line where one side is labeled "Excellent" and the other is labeled "Insufficient." Clinicians are asked to indicate with an X where on the line they would rate their assessment. The line is then measured; scores are recorded as how many mm on the line they are. A score of 0 is excellent and 100 is insufficient.
  • 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 on a scale. The scale is presented as a 100 mm line where one side is labeled "Never" and the other is labeled "Frequent." Clinicians are asked to indicate with an X where on the line they would rate their assessment. The line is then measured; scores are recorded as how many mm on the line they are. A score of 0 is never and 100 is frequent.
  • 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 on a scale. The scale is presented as a 100 mm line where one side is labeled "Simple" and the other is labeled "Complex." Clinicians are asked to indicate with an X where on the line they would rate their assessment. The line is then measured; scores are recorded as how many mm on the line they are. A score of 0 is simple and 100 is complex.
  • 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 on a scale. The scale is presented as a 100 mm line where one side is labeled "Minimal" and the other is labeled "Frequent." Clinicians are asked to indicate with an X where on the line they would rate their assessment. The line is then measured; scores are recorded as how many mm on the line they are. A score of 0 is minimal and 100 is frequent.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HVNI Ambulation Feasibility Study
Official Title  ICMJE Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Insufficiency
  • Dyspnea
Intervention  ICMJE
  • Device: Precision Flow Plus
    High velocity nasal insufflation
  • Device: Treatment as Usual
    Conventional therapy per institution
Study Arms  ICMJE
  • Active Comparator: Treatment as Usual
    Intervention: Device: Treatment as Usual
  • Experimental: High Velocity Nasal Insufflation
    Intervention: Device: Precision Flow Plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 11, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885726
Other Study ID Numbers  ICMJE RP-VTPF2018001Sci
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vapotherm, Inc.
Study Sponsor  ICMJE Vapotherm, Inc.
Collaborators  ICMJE
  • Knox Community Hospital
  • Riverside Regional Medical Center
  • Midwest Chest Consultants
Investigators  ICMJE
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
PRS Account Vapotherm, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP