N/A N=26 Randomized Single-blind Treatment

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

Dyspnea · Hypercapnia · Respiratory Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT04512781 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Patient Vital Signs -- Rated Perceived Dyspnea (RPD) — 3; 2.5; 2.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Control Cannula - Prosoft Cannula - Unicorn Cannula (Device); Control Cannula - Unicorn Cannula - Prosoft Cannula (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vapotherm, Inc.
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Vital Signs -- Rated Perceived Dyspnea (RPD)	3; 2.5; 2.5	—
SECONDARY Patient Vital Signs - Heart Rate [HR]	78; 74; 76	—
SECONDARY Patient Vital Signs - Respiratory Rate [RR]	16; 18; 16	—
SECONDARY Patient Vital Signs - Blood Pressure [BP]	126; 126; 123; 71; 71; 69	—
SECONDARY Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	95; 95; 95	—
SECONDARY Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	53.8; 50.7; 50.3	—

Summary

This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design.

Eligibility Criteria

Inclusion Criteria

Adults, 18 years or older
Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
Severe baseline hypercarbia/hypercapnia of 50 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
Vigorous physical activity should not be performed within 2 hours of testing
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 nasal cannula and HVNI therapy
Agitation or uncooperativeness
Determined by the clinician to be sufficiently unstable or unsuitable for this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04512781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.