Using a breathing support device to help patients with lung injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a non-invasive breathing support device called continuous negative external pressure (CNEP) in improving respiratory function in patients with acute hypoxemic respiratory failure. Participants will be randomly assigned to receive different combinations of high-flow nasal cannula (HFNC) and CNEP at varying pressures. Each treatment strategy will be administered for 45 minutes, with washout periods in between to assess the impact of the device on breathing markers. The goal is to determine if CNEP can enhance oxygenation and overall respiratory support in these patients.

Why it matters

Who can join: the full rules

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 ≥ 30 LPM) initiated within last 96 hours (4 days)
5. FiO2 ≥ 40%
6. SpO2 ≥ 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

Where it's running

• NYU Langone Health - Brooklyn Hospital
  Brooklyn, New York, United States Recruiting
• Bellevue Hospital
  New York, New York, United States Recruiting
• NYU Langone Health - NYU Tisch-Kimmel Hospital
  New York, New York, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Completed

Study contacts

• Principal investigator: Jeremy Beitler, MD, MPH — Columbia University
• Study coordinator: Jeremy Beitler, MD, MPH
• Email: jeremy.beitler@nyulangone.org
• Phone: 646-929-7870

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting HFNC Failure in Acute Hypoxemic Respiratory Failure using Metabolomics and Clinical Data

  This study tests whether metabolomic blood profiles combined with routine clinical data can predict which adults with acute hypoxemic respiratory failure on high-flow nasal cannula will fail and need escalation of care.

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• Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

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• IL-6 guided dexamethasone or tocilizumab treatment for hospitalized acute hypoxemic respiratory failure

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• How changing PEEP affects breathing drive and effort during pressure‑support ventilation

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  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT07203781

• Intubation strategies for adults with acute hypoxemic respiratory failure

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• PEEP tuning in acute respiratory failure using CT and EIT data

  Researchers will look at routine CT and electrical impedance tomography data from adults on mechanical ventilation to see how different PEEP levels relate to lung information, without any new interventions.

  Recruiting Istituto Clinico Humanitas · Milan, Milan · NCT07175194

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.