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

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).

Conditions

Acute Hypoxemic Respiratory Failure

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Acute Hypoxemic Respiratory Failure
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Jeremy Beitler, MD, MPH, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2026-12-31