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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04590014

Enrollment

Registered

2020-10-19

Start date

2022-01-12

Completion date

2022-07-15

Last updated

2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Hypercapnia, Respiratory Insufficiency

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).

Interventions

DEVICEConventional Precision Flow

Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.

DEVICEHVNI HVT2.0 Device

Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Masking description

This trial is non-blinded by necessity, as there are distinct differences in size and appearance between the new and current HVNI device designs.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 - Blood Pressure [BP]	Through study completion, an average of 1.6 hours	Blood pressure (systolic) measured in mmHg
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 - Transcutaneous CO2 [TcPCO2]	Through study completion, an average of 1.6 hours	TcPCO2, measured as percentage of CO2 (%)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Conventional HVNI First New HVNI Second (Randomized) Conventional First, New Second: Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded. Next, patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.	1
New HVNI First, Conventional HVNI Second (Randomized) New First, Conventional Second: Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded. Next, patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.	3
Total	4

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Conventional HVNI First New HVNI Second (Randomized)	New HVNI First, Conventional HVNI Second (Randomized)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	3 Participants	4 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	1 Participants	3 Participants	4 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	1 Participants	3 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 4
other Total, other adverse events	0 / 4	0 / 4
serious Total, serious adverse events	0 / 4	0 / 4

Outcome results

Primary

Patient Vital Signs -- Rated Perceived Dyspnea (RPD)

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.