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

NCT04590014 | Terminated Results FDA Device

• 1 other identifier: RP-VT2.02020001Sci
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Hypercapnia; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Vital Signs - Heart Rate [HR]

  Through study completion, an average of 1.6 hours

• Patient Vital Signs - Respiratory Rate [RR]

  Through study completion, an average of 1.6 hours

• Patient Vital Signs - Blood Pressure [BP]

  Through study completion, an average of 1.6 hours

• Patient Vital Signs - Arterial Oxygen Saturation [SpO2]

  Through study completion, an average of 1.6 hours

• Patient Vital Signs - Transcutaneous CO2 [TcPCO2]

  Through study completion, an average of 1.6 hours

Study Arms (2)

Conventional HVNI First, Then New HVNI Second (Randomized)

EXPERIMENTAL

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.

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

New HVNI First, Then Conventional HVNI Second (Randomized)

EXPERIMENTAL

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.

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

Interventions

Conventional Precision Flow DEVICE

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.

Also known as: Vapotherm Precision Flow

Conventional HVNI First, Then New HVNI Second (Randomized); New HVNI First, Then Conventional HVNI Second (Randomized)

HVNI HVT2.0 Device 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.

Also known as: HVNI Device Vapotherm V2.0

Conventional HVNI First, Then New HVNI Second (Randomized); New HVNI First, Then Conventional HVNI Second (Randomized)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vapotherm, Inc.: lead
• VA Pittsburgh Healthcare System: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Dyspnea; Hypercapnia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Katherine Gerich
• Organization: Vapotherm Inc

kgerich@vtherm.com

5854696753

Study Officials

• Charles Atwood

  VA Pittsburgh Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This trial is non-blinded by necessity, as there are distinct differences in size and appearance between the new and current HVNI device designs.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: January 12, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: March 20, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-02

Locations

US (1)