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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04590014
• Other study ID #: RP-VT2.02020001Sci
• Status: Terminated
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: July 15, 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 a new High Velocity Nasal Insufflation [HVNI] device design to effect ventilation and related physiological responses relative to the current HVNI device design.

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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Hypercapnia
• Respiratory Insufficiency

Intervention

Device:
• Conventional Precision Flow
Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
• HVNI HVT2.0 Device
Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vapotherm, Inc.	VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Through study completion, an average of 1.6 hours
Secondary	Patient Vital Signs - Heart Rate [HR]	Heart rate, measured in beats per minute (bpm)	Through study completion, an average of 1.6 hours
Secondary	Patient Vital Signs - Respiratory Rate [RR]	Respiratory rate, measured in breaths per minute (brpm)	Through study completion, an average of 1.6 hours
Secondary	Patient Vital Signs - Blood Pressure [BP]	Blood pressure (systolic) measured in mmHg	Through study completion, an average of 1.6 hours
Secondary	Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	SpO2 measured as percentage of oxygen saturation (%)	Through study completion, an average of 1.6 hours
Secondary	Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	TcPCO2, measured as percentage of CO2 (%)	Through study completion, an average of 1.6 hours