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HVNI Device

Conventional HVNI First, Then New HVNI Second (Randomized) for Shortness of Breath

N/A

Waitlist Available

Led By Charles Atwood

Research Sponsored by Vapotherm, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1.6 hours

Awards & highlights

Study Summary

This trial will compare how well two different devices help people with breathing.

Eligible Conditions

Shortness of Breath
Hypercapnia
Respiratory Insufficiency

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1.6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1.6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1.6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Vital Signs -- Rated Perceived Dyspnea (RPD)

Secondary outcome measures

Patient Vital Signs - Arterial Oxygen Saturation [SpO2]

Patient Vital Signs - Blood Pressure [BP]

Heart rate

+2 more

Other outcome measures

Clinician Perception Score - Ease of Use

Clinician Perception Score - Expected/Perceived Patient Outcomes

Clinician Perception Score - Frequency of Technical/Clinical Difficulties

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: New HVNI First, Then Conventional HVNI Second (Randomized)Experimental Treatment2 Interventions

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.

Group II: Conventional HVNI First, Then New HVNI Second (Randomized)Experimental Treatment2 Interventions

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Pittsburgh Healthcare SystemFED

32 Previous Clinical Trials

11,404 Total Patients Enrolled

Vapotherm, Inc.Lead Sponsor

11 Previous Clinical Trials

467 Total Patients Enrolled

Charles AtwoodPrincipal InvestigatorVA Pittsburgh Healthcare System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the quota of participants involved in this clinical experiment?

"Confirmed. The details on clinicaltrials.gov attest that this medical experiment, which was advertised on December 1st 2022, is now recruiting potential participants. 32 people are needed from one site for the trial to be successful."

Answered by AI

Are participants being enrolled in this research trial currently?

"According to the clinicaltrials.gov portal, this medical experiment is currently accepting participants. The initial post date was December 1st 2022 and it has since been updated on May 17th of this year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04590014.