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โ† Trials
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Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure

RecruitingNAAges 18 Years - anyAllNYU Langone Health
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 years or older 2. Acute hypoxemic respiratory failure 3. Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan 4. High-flow nasal cannula (flow โ‰ฅ 30 LPM) initiated within last 96 hours (4 days) 5. FiO2 โ‰ฅ 40% 6. SpO2 โ‰ฅ 92% Exclusion Criteria: 1. Do-not-intubate order 2. Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis) 3. Use of cuirass precluded, e.g. due to: * Clinically prescribed prone positioning * Tense ascites * Severe abdominal pain * Abdominal wound or surgery, symptomatic abdominal aortic aneurysm, or other unstable or high-risk intra-abdominal pathology * Pregnancy * Agitated delirium * Body weight \> 180 kg * Burned skin or draining wounds under the planed cuirass area * Indwelling tube/drain entry sites within the planned cuirass seat path 4. Prior intubation during hospital stay 5. Cardiogenic pulmonary edema 6. Exacerbation of asthma or COPD 7. 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 8. Glasgow coma score \< 15 9. Chest tube, pneumothorax, or pneumomediastinum 10. Hemodynamic instability, defined as any of: * Heart rate \< 50 beats/minute * Mean arterial pressure \< 55 mmHg * Norepinephrine-equivalent vasopressor requirement \> 0.1mcg/kg/min 11. Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator) 12. Unreliable pulse-oximetry tracing 13. Imminent intubation 14. Anticipated lack of patient availability to complete study procedures (e.g. due to planned clinical procedure such as CT scan or dialysis during potential time of study) 15. Attending physician refusal 16. Lack of capacity for direct consent
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What it tests

  • HFNC only
  • HFNC + CNEP10
  • HFNC + CNEP20
  • HFNC + CNEP30
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Where

4 sites
NYU Langone Health - Brooklyn Hospital
Brooklyn, United States
Bellevue Hospital
New York, United States
NYU Langone Health - NYU Tisch-Kimmel Hospital
New York, United States
Columbia University Irving Medical Center
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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