NCT05675345NARecruiting

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

NYU Langone Health

Start Date

2/28/2024

Completion Date

6/30/2027

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).

Detailed Description

This study is a prospective randomized cross-over trial. Eligible, consenting participants will undergo 4 strategies of respiratory support: high-flow nasal cannula (HFNC) only, HFNC + continuous negative external pressure (CNEP) of 10 cmH2O, HFNC + CNEP of 20 cmH2O, HFNC + CNEP of 30 cmH2O. Throughout the study period, HFNC will be managed at a constant flow rate with fraction of inspired oxygen (FiO2) titrated to achieve goal oxygen saturation (SpO2) of 90-97%, measured via continuous pulse-oximetry. Each of the 4 strategies will be performed for 45 minutes per strategy, interspersed with a 15-minute washout period of HFNC only. Participants will be randomized to the sequence of strategies for respiratory support. A summary of the sequence of trial procedures is as follows: 1. Perform baseline measures. 2. Wait 5-10 minutes for recovery. 3. Initiate first random treatment assignment for up to 45 minutes. 4. HFNC-only washout for 15 minutes 5. Initiate second random treatment assignment for up to 45 minutes. 6. HFNC-only washout for 15 minutes 7. Initiate third random treatment assignment for up to 45 minutes. 8. HFNC-only washout for 15 minutes 9. Initiate fourth random treatment assignment for up to 45 minutes. 10. Return to usual care (HFNC only) If a participant does not tolerate a given level of CNEP, the patient will be returned to HFNC for 5 minutes and then given the option to attempt that CNEP level again. If the patient declines reattempt or does not tolerate that CNEP level on reattempt, the HFNC-only washout will be instituted for 15 minutes before proceeding to the next protocol step.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

HFNC only

DEVICE

HFNC + CNEP10

DEVICE

HFNC + CNEP20

DEVICE

HFNC + CNEP30

Interested in This Trial?

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Conditions

Acute Hypoxemic Respiratory Failure

Locations

NYU Langone Health - Brooklyn Hospital

Brooklyn, New York 11220

United States

Bellevue Hospital

New York, New York 10016

United States

NYU Langone Health - NYU Tisch-Kimmel Hospital

New York, New York 10016

United States

Columbia University Irving Medical Center

New York, New York 10032

United States