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

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

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.

Completed
Critical Illness
ARDS
Eligibility Criteria

Inclusion Criteria:

1. Patients with positive SARS-CoV-2 infection*

2. Patients with ARDS under mechanical ventilation**

3. 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:

1. Contraindication for EIT monitoring

1. Unstable spine or pelvic fractures

2. Pacemaker, automatic implantable cardioverter defibrillator

3. Skin lesions between the 4th and 5th ribs where the EIT belt is worn

2. Home mechanical ventilation before inclusion

3. Pregnancy

4. DNR (do-not-resuscitate)

5. Increased intracranial pressure (> 18 mmHg)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Japan
Locations

Osaka University Hospital
Suita, Osaka, Japan

Takeshi Yoshida, M.D., Ph.D., Principal Investigator
Osaka University

Hospital Rebagliati
NCT Number
Keywords
SARS-CoV-2
Electrical Impedance Tomography
positive end expiratory pressure
MeSH Terms
Pneumonia
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Critical Illness