Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure

Launched by COLUMBIA UNIVERSITY · Dec 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new breathing support device designed to help patients with acute hypoxemic respiratory failure, which is a serious condition where the lungs struggle to get enough oxygen into the blood. The device, called continuous negative external pressure (CNEP), is a plastic shell that sits over the chest and abdomen and uses a vacuum to help the chest expand while breathing. Researchers want to find out if this device can improve breathing in patients who are already receiving high-flow oxygen.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with acute hypoxemic respiratory failure. They should also be on high-flow oxygen support. However, certain conditions, like severe lung disease or specific anatomical issues, may prevent someone from participating. If you join the study, you can expect to wear the device for a period of time while doctors monitor its effects on your breathing. This research could eventually help improve treatment options for patients with similar breathing challenges.

Gender

ALL

Eligibility 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