Actively Recruiting
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Led by Columbia University · Updated on 2024-03-04
20
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest/abdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).
CONDITIONS
Official Title
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute hypoxemic respiratory failure
- Non-cardiogenic airspace opacities visible on chest X-ray or CT scan
- High-flow nasal cannula oxygen therapy with flow rate of 30 LPM or higher started within the last 96 hours
- Fraction of inspired oxygen (FiO2) of 40% or higher
- Oxygen saturation (SpO2) of 92% or higher
You will not qualify if you...
- Do-not-intubate order in place
- Anatomical issues preventing proper fit of the breathing device, such as severe kyphosis or scoliosis
- Conditions preventing use of the device, including prescribed prone positioning, tense ascites, severe abdominal pain, abdominal wounds or recent surgery, pregnancy, or agitated delirium
- Previous intubation during the current hospital stay
- Cardiogenic pulmonary edema
- Asthma or COPD flare-up
- Chronic lung diseases like interstitial lung disease, cystic fibrosis, lung masses or cancer, lung transplant, or need for home oxygen
- Glasgow coma score less than 15
- Presence of chest tube, pneumothorax, or pneumomediastinum
- Hemodynamic instability defined by low blood pressure or high vasopressor use
- Having an implantable electrical device such as pacemaker or defibrillator
- Unreliable oxygen saturation monitoring
- Imminent need for intubation
- Expected inability to complete study procedures due to planned clinical treatments
- Refusal by attending physician to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Jeremy Beitler, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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