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Recruiting NCT05675345

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

Trial Parameters

Condition Acute Hypoxemic Respiratory Failure
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-02-28
Completion 2026-12-31
Interventions
HFNC onlyHFNC + CNEP10HFNC + CNEP20

Brief Summary

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).

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 instab

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