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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:

* 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

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: Columbia University · Participants: 20 · Started: Feb 28, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05675345

Locations in the U.S.

New YorkColumbia University Irving Medical Center, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.