RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-02-28
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05675345

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion 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%
  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:
  4. * Clinically prescribed prone positioning
  5. * Tense ascites
  6. * Severe abdominal pain
  7. * Abdominal wound or surgery
  8. * Pregnancy
  9. * Agitated delirium
  10. * Prior intubation during hospital stay
  11. * Cardiogenic pulmonary edema
  12. * Exacerbation of asthma or COPD
  13. * Chronic lung disease, including:
  14. * Interstitial lung disease
  15. * Cystic fibrosis
  16. * Lung mass, lung cancer, or metastasis to the lung
  17. * Lung transplant recipient
  18. * Any disease that requires home oxygen
  19. * Glasgow coma score \< 15
  20. * Chest tube, pneumothorax, or pneumomediastinum
  21. * Hemodynamic instability (mean arterial pressure \< 55 mmHg or norepinephrine-equivalent vasopressor requirement \> 0.1mcg/kg/min)
  22. * Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)
  23. * Unreliable pulse-oximetry tracing
  24. * Imminent intubation
  25. * 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)
  26. * Attending physician refusal

Contacts and Locations

Study Contact

Jeremy Beitler, MD, MPH
CONTACT
212-305-0334
jrb2266@cumc.columbia.edu

Principal Investigator

Jeremy Beitler, MD, MPH
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Columbia University

  • Jeremy Beitler, MD, MPH, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-28
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-02-28
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • acute respiratory distress syndrome
  • noninvasive ventilation
  • mechanical ventilation
  • oxygen inhalation therapy
  • atelectasis
  • high-flow nasal cannula

Additional Relevant MeSH Terms

  • Acute Hypoxemic Respiratory Failure