Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography

Study Overview
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Brief Summary
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Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to SARS-CoV-2 pneumonia.

Detailed Description
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The multi-center prospective observational study will enroll 20 adult ARDS patients under mechanical ventilation from Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be waived due to the nature of observational study. Patients with positive SARS-CoV-2 infection will be included. Prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. The distribution of ventilation will be evaluated with EIT.

Official Title
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Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study

Conditions
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Critical Illness, ARDS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with positive SARS-CoV-2 infection＊ Patients with ARDS under mechanical ventilation＊＊ Patients ≧ 18 years old Definition of SARS-CoV-2 infection positive: SARS-CoV-2 infection is defined as being positive in RT-PCR (real time reverse transcriptase-polymerase chain reaction) assay using nasal or pharyngeal swab samples. Definition of ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 300 mmHg with PEEP ≧ 5 cmH2O) Exclusion Criteria: Contraindication for EIT monitoring Unstable spine or pelvic fractures Pacemaker, automatic implantable cardioverter defibrillator Skin lesions between the 4th and 5th ribs where the EIT belt is worn Home mechanical ventilation before inclusion Pregnancy DNR (do-not-resuscitate) Increased intracranial pressure (> 18 mmHg)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution of ventilation | The distribution of ventilation measured by EIT at PEEP 5 and 15. | Through study completion (up to 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silent spaces | The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15. | Through study completion (up to 24 hours) | 
| Respiratory system compliance | Respiratory system compliance in PEEP 5 and 15. | Through study completion (up to 24 hours) | 
| Oxygenation | Oxygenation in PEEP 5 and 15. | Through study completion (up to 24 hours) | 
| Dead space ventilation ratio | Dead space ventilation ratio in PEEP 5 and 15. | Through study completion (up to 24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, electrical impedance tomography, positive end expiratory pressure