Using a breathing support device to help patients with lung injury
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial
This study is testing if a new breathing support device can help people with lung injuries breathe better and get more oxygen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05675345 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older experiencing acute hypoxemic respiratory failure with specific lung imaging findings.
Not a fit: Patients with chronic lung diseases or those who have a do-not-intubate order may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for patients suffering from acute hypoxemic respiratory failure.
How similar studies have performed: While the use of CNEP is a novel approach, similar studies exploring non-invasive ventilation strategies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Acute hypoxemic respiratory failure * Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan * High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days) * FiO2 ≥ 40% * SpO2 ≥ 92% Exclusion Criteria: * Do-not-intubate order * Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis) * Use of cuirass precluded, e.g. due to: * Clinically prescribed prone positioning * Tense ascites * Severe abdominal pain * Abdominal wound or surgery * Pregnancy * Agitated delirium * Prior intubation during hospital stay * Cardiogenic pulmonary edema * Exacerbation of asthma or COPD * 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 * Glasgow coma score \< 15 * Chest tube, pneumothorax, or pneumomediastinum * Hemodynamic instability (mean arterial pressure \< 55 mmHg or norepinephrine-equivalent vasopressor requirement \> 0.1mcg/kg/min) * Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator) * Unreliable pulse-oximetry tracing * Imminent intubation * 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) * Attending physician refusal
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jeremy Beitler, MD, MPH — Columbia University
- Study coordinator: Jeremy Beitler, MD, MPH
- Email: jrb2266@cumc.columbia.edu
- Phone: 212-305-0334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.