Recruiting

CNEP

Sponsor:

Columbia University

Code:

NCT05675345

Conditions

Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HFNC only

HFNC + CNEP10

HFNC + CNEP20

HFNC + CNEP30

Study Details

Brief summary:

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

Study ID

NCT05675345

Start date

Feb 28, 2024

Status verified date

Feb, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: HFNC only

experimental: HFNC + CNEP10

experimental: HFNC + CNEP20

experimental: HFNC + CNEP30

Interventions

HFNC only

HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

HFNC + CNEP10

HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

HFNC + CNEP20

HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

HFNC + CNEP30

HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Primary outcome measure

  • Change from baseline in SpO2/FiO2 [ Time Frame: At the end of each treatment period, up to 45 minutes ]

Central Contacts and Locations

Central contacts

Jeremy Beitler, MD, MPH

212-305-0334jrb2266@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jeremy Beitler, MD, MPH

212-305-0334jrb2266@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Mar 4, 2024

Last verified

Feb, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2024-03-04.