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

Not Applicable

Completed

Interventions: Device: Control Cannula - Unicorn Cannula - Prosoft Cannula
Device: Control Cannula - Prosoft Cannula - Unicorn Cannula

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula	Control Cannula - Unicorn Cannula - Prosoft Cannula	During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters will be recorded. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula	Control Cannula - Prosoft Cannula - Unicorn Cannula	During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters will be recorded. Patients will be randomly assigned to Prosoft or Unicorn cannula testing groups. Physiologic and ventilation parameters will be recorded.

Primary Outcome Measures

Name	Time	Method
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)	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 Outcome Measures

Name	Time	Method
Patient Vital Signs - Heart Rate [HR]	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.
Patient Vital Signs - Respiratory Rate [RR]	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)
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	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 (%)
Patient Vital Signs - Blood Pressure [BP]	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
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	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 (%)

Locations (2): VA Pittsburgh Healthcare System
🇺🇸
Pittsburgh, Pennsylvania, United States
Erlanger Baroness Hospital
🇺🇸
Chattanooga, Tennessee, United States