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

Not Applicable

Terminated

• Conditions: Hypercapnia; Respiratory Insufficiency; Dyspnea

• Registration Number: NCT04590014
• Lead Sponsor: Vapotherm, Inc.

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.

Detailed Description

The objective of this study is to evaluate the ability of a new HVNI device to improve ventilation, dyspnea, and related physiological responses relative to the conventional Precision Flow device design, with which there are published clinical outcomes data. It is hypothesized that the new HVNI device design (V2.0) will be comparable at relieving patient dyspnea when compared to the conventional HVNI device design (Precision Flow).

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2022-01-12
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Results First Submitted: 2023-11-22
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-23
• Last Update Submitted: 2024-02-23
• Results First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)	Through study completion, an average of 1.6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Patient Vital Signs - Heart Rate [HR]	Through study completion, an average of 1.6 hours	Heart rate, measured in beats per minute (bpm)
Patient Vital Signs - Respiratory Rate [RR]	Through study completion, an average of 1.6 hours	Respiratory rate, measured in breaths per minute (brpm)
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]	Through study completion, an average of 1.6 hours	TcPCO2, measured as percentage of CO2 (%)
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]	Through study completion, an average of 1.6 hours	SpO2 measured as percentage of oxygen saturation (%)
Patient Vital Signs - Blood Pressure [BP]	Through study completion, an average of 1.6 hours	Blood pressure (systolic) measured in mmHg

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States