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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512781
• Other study ID #: RP-VTPF2018002Sci
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 7, 2022

Study information

• Verified date: February 2024
• Source: Vapotherm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Hypercapnia
• Respiratory Insufficiency

Intervention

Device:
• Control Cannula - Prosoft Cannula - Unicorn Cannula
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
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.

Locations

Country	Name	City	State
United States	Erlanger Baroness Hospital	Chattanooga	Tennessee
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Vapotherm, Inc.	Erlanger Baroness Hospital, VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician Perception Score - Frequency of Technical/Clinical Difficulties	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.	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	Clinician Perception Score - Patient Comfort/Tolerance	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.	Through study completion, an average of 3 hours
Other	Clinician Perception Score - Ease of Use	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.	Through study completion, an average of 3 hours
Other	Clinician Perception Score - Monitoring & Support for Therapy	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.	Through study completion, an average of 3 hours
Other	Clinician Perception Score - Expected/Perceived Patient Outcomes	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.	Through study completion, an average of 3 hours
Other	Patient Perception Score - Relief of Symptoms	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.	Through study completion, an average of 3 hours
Other	Patient Perception Score - Comfort/Tolerance of Therapy	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.	Through study completion, an average of 3 hours
Primary	Patient Vital Signs -- Rated Perceived Dyspnea (RPD)	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.	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	Patient Vital Signs - Heart Rate [HR]	Heart Rate (HR) The number of beats per minute.	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	Patient Vital Signs - Respiratory Rate [RR]	Respiratory rate, measured in breaths per minute (brpm)	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	Patient Vital Signs - Blood Pressure [BP]	Blood pressure (systolic) measured in mmHg	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	Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	SpO2 measured as percentage of oxygen saturation (%)	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	Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	TcPCO2 measured as percentage of CO2 (%)	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)