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HVNI Cannula

Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula for Shortness of Breath

N/A

Waitlist Available

Led By Charles W Atwood, MD, FCCP

Research Sponsored by Vapotherm, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial will test if a new type of nasal cannula can improve ventilation for patients.

Eligible Conditions

Shortness of Breath
Respiratory Insufficiency
Hypercapnia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) 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]

Patient Vital Signs - Heart Rate [HR]

+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: Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft CannulaExperimental Treatment1 Intervention

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.

Group II: Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn CannulaExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control Cannula - Prosoft Cannula - Unicorn Cannula

2020

N/A

~30

Control Cannula - Unicorn Cannula - Prosoft Cannula

2020

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Pittsburgh Healthcare SystemFED

32 Previous Clinical Trials

11,383 Total Patients Enrolled

Erlanger Baroness HospitalUNKNOWN

1 Previous Clinical Trials

73 Total Patients Enrolled

Vapotherm, Inc.Lead Sponsor

11 Previous Clinical Trials

446 Total Patients Enrolled

Frequently Asked Questions

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

To what extent is this trial catering to the needs of participants?

"Affirmative. According to the information on clinicaltrials.gov, this experiment is actively enrolling participants; it was initially published on October 1st 2020 and revised most recently on May 17th 2022. 32 people will be accepted across 2 trial sites."

Answered by AI

Are any slots available for prospective participants of this experiment?

"Per clinicaltrials.gov, this investigation is currently in need of participants. The study was originally published on October 1st 2020 and has most recently been modified on May 17th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04512781.