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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
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 moreOther study objectives
Clinician Perception Score - Ease of Use
Clinician Perception Score - Expected/Perceived Outcomes
Clinician Perception Score - Patient Comfort/Tolerance
+2 moreAwards & 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
Find a Location
Who is running the clinical trial?
University of MarylandOTHER
168 Previous Clinical Trials
304,873 Total Patients Enrolled
George Washington UniversityOTHER
253 Previous Clinical Trials
466,482 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
17,770 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You require help to protect your airway.You have a blockage in your nose that is causing a problem with breathing.You have a high level of carbon dioxide in your blood, measured at 60 mmHg or higher.You are not breathing on your own or you have a condition that makes using high velocity nasal insufflation not safe for you.You have sudden breathing problems with too much carbon dioxide in your blood.You have serious problems with your body's metabolism, such as a suspected drug overdose or a disorder affecting the balance of acids and bases in your body.Criterion: You require immediate placement of a breathing tube.You have been diagnosed with pneumonia and have significant signs of it on a chest x-ray.You have congestive heart failure as your main health issue.Your blood pH is between 7.0 and 7.35.You had a serious breathing problem when you came in for the study.You are 18 years or older and have been diagnosed with or are suspected to have COPD.
Research Study Groups:
This trial has the following groups:- Group 1: High Velocity Nasal Insufflation (HVNI)
- Group 2: Noninvasive Positive Pressure Ventilation (NIPPV)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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