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Device
CNEP + HFNC for Respiratory Insufficiency
N/A
Recruiting
Led By Jeremy Beitler, MD, MPH
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute hypoxemic respiratory failure
FiO2 ≥ 40%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of each treatment period, up to 45 minutes
Awards & highlights
Study Summary
This trial is testing a breathing support device to see if it can improve breathing in patients with lung injury. The device uses a plastic shell and vacuum to help the chest expand with breathing. Results will show if it can help those with acute hypoxemic respiratory failure.
Who is the study for?
Adults with non-heart-related lung injury needing high-flow oxygen can join this trial. They must have started using a high-flow nasal cannula within the last four days and maintain certain oxygen levels. People with unreliable pulse-oximetry, chest injuries, severe blood pressure issues, do-not-intubate orders, or conditions affecting device fit like severe spine curvature cannot participate.Check my eligibility
What is being tested?
The study tests if a non-invasive breathing support device called CNEP improves breathing in patients with acute hypoxemic respiratory failure. Participants will receive different levels of negative pressure (CNEP30, CNEP20, CNEP10) along with standard high-flow nasal cannula therapy to see which works best.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device over the chest/abdomen and possible skin irritation where it fits. Since it's non-invasive, risks are lower compared to invasive procedures but could also include difficulty tolerating the sensation of negative pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am experiencing severe difficulty breathing due to low oxygen levels.
Select...
I need a high level of oxygen support.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of each treatment period, up to 45 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of each treatment period, up to 45 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in SpO2/FiO2
Secondary outcome measures
Change from baseline in Blood Pressure
Change from baseline in Breathing Discomfort
Change from baseline in Heart Rate
+10 moreOther outcome measures
Change from baseline in Anteroposterior Ventilation Ratio
Change from baseline in End-Expiratory Lung Volume
Change from baseline in Minute Ventilation
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: HFNC + CNEP30Experimental Treatment1 Intervention
Group II: HFNC + CNEP20Experimental Treatment1 Intervention
Group III: HFNC + CNEP10Experimental Treatment1 Intervention
Group IV: HFNC onlyActive Control1 Intervention
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,239 Total Patients Enrolled
Jeremy Beitler, MD, MPHPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing severe difficulty breathing due to low oxygen levels.My doctor has advised against me joining the trial.You have a medical order that says not to use a breathing tube.Your oxygen levels are at least 92%.Your Glasgow coma score is less than 15.I have a chronic lung condition or require home oxygen.I need a high level of oxygen support.I cannot use a cuirass due to specific health conditions or recent medical procedures.I am available for all study procedures and have no conflicting appointments.I started using a high-flow nasal cannula within the last 4 days.Unstable or inconsistent pulse-oximetry readings.I have had a chest tube, pneumothorax, or pneumomediastinum.I am 18 years old or older.You have abnormal findings in your chest X-ray or CT scan that are not related to heart problems.I am about to be put on a ventilator.Your blood pressure is too low or you need a high dose of medication to keep your blood pressure stable.You have a severe curvature of the spine that would make it difficult to wear the cuirass.
Research Study Groups:
This trial has the following groups:- Group 1: HFNC only
- Group 2: HFNC + CNEP30
- Group 3: HFNC + CNEP20
- Group 4: HFNC + CNEP10
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.
Is enrollment still available for this research endeavor?
"According to the information hosted by clinicaltrials.gov, this medical trial is not currently recruiting patients; though it was first posted on March 15th 2023 and last updated December 29th 2022. There are however 166 other trials with active recruitment efforts underway as of now."
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