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Completed

NCT Number: NCT04512781

Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs

This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design.

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Key information

Conditions

Dyspnea Hypercapnia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States

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About this study

The objective of this study is to evaluate the ability of HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design, with which there are published clinical outcomes data. It is hypothesized that next generation nasal cannula designs (Prosoft and Unicorn) will be comparable at relieving patient dyspnea while on HVNI, when compared to the conventional (Legacy) cannula.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, 18 years or older
  • Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
  • Severe baseline hypercarbia/hypercapnia of 50 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas

Exclusion criteria

  • Patient has unstable cardiovascular condition
  • Significant unilateral or bilateral nasal occlusion
  • Vigorous physical activity should not be performed within 2 hours of testing
  • Inability to provide informed consent
  • Pregnancy
  • Known contraindication to perform steps of the protocol
  • Absence of spontaneous respiration or known contraindication to HVNI
  • Inability to use nasal cannula and HVNI therapy
  • Agitation or uncooperativeness
  • Determined by the clinician to be sufficiently unstable or unsuitable for this study

Treatment and study plan

Control Cannula - Prosoft Cannula - Unicorn Cannula

Device

The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.

Control Cannula - Unicorn Cannula - Prosoft Cannula

Device

The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.

Primary outcomes

  1. Patient Vital Signs -- Rated Perceived Dyspnea (RPD)

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    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.

Secondary outcomes

  1. Patient Vital Signs - Heart Rate [HR]

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    Heart Rate (HR) The number of beats per minute.

  2. Patient Vital Signs - Respiratory Rate [RR]

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    Respiratory rate, measured in breaths per minute (brpm)

  3. Patient Vital Signs - Blood Pressure [BP]

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    Blood pressure (systolic) measured in mmHg

  4. Patient Vital Signs - Arterial Oxygen Saturation [SpO2]

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    SpO2 measured as percentage of oxygen saturation (%)

  5. Patient Vital Signs - Transcutaneous CO2 [TcPCO2]

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    TcPCO2 measured as percentage of CO2 (%)

Other outcomes

  1. Clinician Perception Score - Frequency of Technical/Clinical Difficulties

    Time frame: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)

    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.

  2. Clinician Perception Score - Patient Comfort/Tolerance

    Time frame: Through study completion, an average of 3 hours

    Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  3. Clinician Perception Score - Ease of Use

    Time frame: Through study completion, an average of 3 hours

    Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  4. Clinician Perception Score - Monitoring & Support for Therapy

    Time frame: Through study completion, an average of 3 hours

    Clinician's subjective assessment of the level of monitoring and support for therapy required during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  5. Clinician Perception Score - Expected/Perceived Patient Outcomes

    Time frame: Through study completion, an average of 3 hours

    Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  6. Patient Perception Score - Relief of Symptoms

    Time frame: Through study completion, an average of 3 hours

    Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  7. Patient Perception Score - Comfort/Tolerance of Therapy

    Time frame: Through study completion, an average of 3 hours

    Patient's subjective assessment of their comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

Sponsors and collaborators

Lead sponsor

Vapotherm, Inc.

Industry

Collaborators

  • Erlanger Baroness Hospital
  • VA Pittsburgh Healthcare System

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2020
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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