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Respiratory Support

NIPPV vs HVNI for Hypercapnia (HYPERACT Trial)

N/A

Waitlist Available

Led By Jessica Whittle, MD, PhD, FACEP

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 during four time points in the study; baseline, 30 min, 60 min, and 240 min

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare HVNI to another breathing support method in COPD patients with severe breathing problems. HVNI delivers oxygen quickly through the nose to help clear carbon dioxide and ease breathing.

Who is the study for?

This trial is for adults over 18 with COPD who are experiencing acute hypercapnic respiratory failure, have a PCO2 level of 60 mmHg or higher, and a venous pH between 7.0 - 7.35. It's not suitable for those unstable for the study, extremely agitated, needing airway protection or emergent intubation, with significant nasal blockage, pneumonia correlated with chest x-ray findings, heart failure as primary condition, respiratory arrest on presentation, pregnant women or unable to consent.

What is being tested?

The study compares two treatments for patients with high levels of carbon dioxide in their blood: High Velocity Nasal Insufflation (HVNI) versus Noninvasive Positive Pressure Ventilation (NIPPV). The goal is to see which method better helps ventilation and improves physiological responses in these patients.

What are the potential side effects?

Possible side effects may include discomfort from wearing the devices used in NIPPV or HVNI therapy such as skin irritation around the mask area or nosebleeds due to high flow rates; however specific side effects will depend on individual patient response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during four time points in the study over the course of four hours; baseline, 30 min, 60 min, and 240 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during four time points in the study over the course of four hours; baseline, 30 min, 60 min, and 240 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and during four time points in the study over the course of four hours; baseline, 30 min, 60 min, and 240 min for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rated Perceived Dyspnea [RPD]

Secondary study objectives

Patient Base Excess - Base Excess

Patient Basic Metabolic Panel - Chloride

Patient Basic Metabolic Panel - Glucose

+10 more

Other study objectives

Clinician Perception Score - Ease of Use

Clinician Perception Score - Expected/Perceived Outcomes

Clinician Perception Score - Patient Comfort/Tolerance

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Velocity Nasal Insufflation (HVNI)Experimental Treatment1 Intervention

Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.

Group II: Noninvasive Positive Pressure Ventilation (NIPPV)Active Control1 Intervention

Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High Velocity Nasal Insufflation (HVNI)

2020

N/A

~70

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