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

Recruiting

Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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).

What is being tested

Sponsor: NYU Langone Health · Participants: 20 · Started: Feb 28, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05675345

Locations in the U.S.

New YorkNYU Langone Health - Brooklyn Hospital, Brooklyn
Bellevue Hospital, New York
NYU Langone Health - NYU Tisch-Kimmel Hospital, New York

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.