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

Vapotherm

Status: Completed

Conditions: Dyspnea; Hypercapnia; Respiratory Insufficiency

Treatments: Device: Control Cannula - Unicorn Cannula - Prosoft Cannula; Device: Control Cannula - Prosoft Cannula - Unicorn Cannula

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; Other

Identifiers

NCT04512781

RP-VTPF2018002Sci

Details and patient eligibility

About

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.

Full description

The objective of this study is to evaluate the ability of HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design, with which there are published clinical outcomes data. It is hypothesized that next generation nasal cannula designs (Prosoft and Unicorn) will be comparable at relieving patient dyspnea while on HVNI, when compared to the conventional (Legacy) cannula.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula

Experimental group

Description:

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.

Treatment:

Device: Control Cannula - Prosoft Cannula - Unicorn Cannula

Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula

Experimental group

Description:

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.

Treatment:

Device: Control Cannula - Unicorn Cannula - Prosoft Cannula