Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Recruiting now · Not applicable
Conditions studied: Acute Hypoxemic Respiratory Failure
In brief
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).
Key facts
- Study ID
- NCT05675345
- Run by
- Columbia University
- People needed
- 20
- Starts
- 2024-02-28
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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)
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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