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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 at study end, 4 hours from study start
Awards & highlights
HYPERACT Trial Summary
This trial will compare the effectiveness of two methods of mechanical ventilation - one using a machine to deliver high-pressure air through the nose, and the other using a mask to deliver air pressure through the mouth - in patients with hypercapnia.
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.Check my eligibility
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.See study design
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.
HYPERACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study end, 4 hours from study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study end, 4 hours from study start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rated Perceived Dyspnea [RPD]
Secondary outcome measures
Patient Base Excess - Base Excess
Patient Basic Metabolic Panel - Chloride
Patient Basic Metabolic Panel - Glucose
+12 moreOther outcome measures
Clinician Perception Score - Ease of Use
Clinician Perception Score - Expected/Perceived Outcomes
Clinician Perception Score - Patient Comfort/Tolerance
+2 moreHYPERACT 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.
Find a Location
Who is running the clinical trial?
University of MarylandOTHER
160 Previous Clinical Trials
302,210 Total Patients Enrolled
George Washington UniversityOTHER
243 Previous Clinical Trials
453,701 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
18,131 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted into this clinical experiment?
"In order to commence this study, 80 qualified candidates must be identified. The trial is being sponsored by Vapotherm, Inc., and the locations recruiting patients include Erlanger Health System in Chattanooga, Tennessee and Cooper University Hospital in Camden, New jersey."
Answered by AI
Are there presently any opportunities for people to participate in the trial?
"Clinicaltrials.gov reflects that this clinical trial, which was initially posted on November 11th 2020, is currently searching for participants. The information provided by the website has been recently updated as of May 17th 2022."
Answered by AI
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