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

Sponsor: NYU Langone Health • ClinicalTrials.gov ID: NCT05675345

Registry updated: 2026-10-01

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Description

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).

Interventions

HFNC only (Device)
HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC + CNEP10 (Device)
HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC + CNEP20 (Device)
HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC + CNEP30 (Device)
HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Eligibility criteria

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

Conditions

Acute Hypoxemic Respiratory Failure

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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