Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence

Not Applicable

Terminated

Conditions: Hypercapnia
Respiratory Insufficiency
Dyspnea

Interventions: Device: Conventional Precision Flow
Device: HVNI HVT2.0 Device

Registration Number: NCT04590014

Lead Sponsor: Vapotherm, Inc.

Brief Summary: This study will evaluate the ability of a new High Velocity Nasal Insufflation \[HVNI\] device design to effect ventilation and related physiological responses relative to the current HVNI device design.

Detailed Description: The objective of this study is to evaluate the ability of a new HVNI device to improve ventilation, dyspnea, and related physiological responses relative to the conventional Precision Flow device design, with which there are published clinical outcomes data. It is hypothesized that the new HVNI device design (V2.0) will be comparable at relieving patient dyspnea when compared to the conventional HVNI device design (Precision Flow).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

Inclusion Criteria

Adult inpatients (18 years of age and older)
Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
Severe baseline hypercarbia/hypercapnia of 55 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
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 HVNI therapy
Agitation or uncooperativeness
Determined by the clinician to be sufficiently unstable or unsuitable for this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional HVNI First, Then New HVNI Second (Randomized)	Conventional Precision Flow	The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.
Conventional HVNI First, Then New HVNI Second (Randomized)	HVNI HVT2.0 Device	The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.
New HVNI First, Then Conventional HVNI Second (Randomized)	HVNI HVT2.0 Device	The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.
New HVNI First, Then Conventional HVNI Second (Randomized)	Conventional Precision Flow	The purpose of this intervention is to evaluate the efficacy of the conventional HVNI device design (Precision Flow) to provide targeted relief of dyspnea. The purpose of this intervention is to evaluate the efficacy of a new HVNI device design (V2.0) to provide targeted relief of dyspnea.

Primary Outcome Measures

Name	Time	Method
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)	Through study completion, an average of 1.6 hours	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]	Through study completion, an average of 1.6 hours	Heart rate, measured in beats per minute (bpm)
Patient Vital Signs - Respiratory Rate [RR]	Through study completion, an average of 1.6 hours	Respiratory rate, measured in breaths per minute (brpm)
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	Through study completion, an average of 1.6 hours	TcPCO2, measured as percentage of CO2 (%)
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	Through study completion, an average of 1.6 hours	SpO2 measured as percentage of oxygen saturation (%)
Patient Vital Signs - Blood Pressure [BP]	Through study completion, an average of 1.6 hours	Blood pressure (systolic) measured in mmHg