Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial
Columbia University
20 participants
Feb 28, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria26
- 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
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Interventions
HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05675345