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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%
Must not have
Chronic lung disease, including interstitial lung disease, cystic fibrosis, lung mass, lung cancer, or metastasis to the lung, lung transplant recipient, any disease that requires home oxygen
Chest tube, pneumothorax, or pneumomediastinum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of each treatment period, up to 45 minutes
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a chronic lung condition or require home oxygen.
Select...
I have had a chest tube, pneumothorax, or pneumomediastinum.
Select...
I am about to be put on a ventilator.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of each treatment period, up to 45 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of each treatment period, up to 45 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in SpO2/FiO2
Secondary study objectives
Change from baseline in Blood Pressure
Change from baseline in Breathing Discomfort
Change from baseline in Heart Rate
+10 more
Other study objectives
Change from baseline in Anteroposterior Ventilation Ratio
Change from baseline in End-Expiratory Lung Volume
Change from baseline in Minute Ventilation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,767,105 Total Patients Enrolled
Jeremy Beitler, MD, MPHPrincipal InvestigatorColumbia University

Media Library

CNEP10 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05675345 — N/A
Hypoxemic Respiratory Failure Research Study Groups: HFNC + CNEP20, HFNC + CNEP30, HFNC only, HFNC + CNEP10
Hypoxemic Respiratory Failure Clinical Trial 2023: CNEP10 Highlights & Side Effects. Trial Name: NCT05675345 — N/A
CNEP10 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675345 — N/A
~13 spots leftby Dec 2026
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