Recruiting

CNEP

Sponsor:

NYU Langone Health

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

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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

Locations

NYU Langone Health - Brooklyn Hospital

Recruiting

Brooklyn, New York, United States, 11220

Bellevue Hospital

Recruiting

New York, New York, United States, 10016

NYU Langone Health - NYU Tisch-Kimmel Hospital

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

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 2026-10-24. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.