Clinical trial NCT04512781: Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
Official title: Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Hypercapnia
Respiratory Insufficiency
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: VA Pittsburgh Healthcare System
name: Erlanger Baroness Hospital
First posted: 2020-08-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
timeFrame: 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)
Secondary outcomes:
measure: Patient Vital Signs - Heart Rate [HR]
timeFrame: 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)
measure: Patient Vital Signs - Respiratory Rate [RR]
timeFrame: 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)
measure: Patient Vital Signs - Blood Pressure [BP]
timeFrame: 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)
measure: Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
timeFrame: 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)
measure: Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
timeFrame: 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)
Other outcomes:
measure: Clinician Perception Score - Frequency of Technical/Clinical Difficulties
timeFrame: 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)
measure: Clinician Perception Score - Patient Comfort/Tolerance
timeFrame: Through study completion, an average of 3 hours
measure: Clinician Perception Score - Ease of Use
timeFrame: Through study completion, an average of 3 hours
measure: Clinician Perception Score - Monitoring & Support for Therapy
timeFrame: Through study completion, an average of 3 hours
measure: Clinician Perception Score - Expected/Perceived Patient Outcomes
timeFrame: Through study completion, an average of 3 hours
measure: Patient Perception Score - Relief of Symptoms
timeFrame: Through study completion, an average of 3 hours
measure: Patient Perception Score - Comfort/Tolerance of Therapy
timeFrame: Through study completion, an average of 3 hours
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Baroness Hospital
state: Tennessee
Study officials:
affiliation: VA Pittsburgh Healthcare System
name: Charles W Atwood, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Erlanger Baroness Hospital
name: Jigme M Sethi, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References: