Clinical trial NCT04473300: Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography
Official title: Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
ARDS
Keywords: SARS-CoV-2
electrical impedance tomography
positive end expiratory pressure
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Hospital Rebagliati
First posted: 2020-07-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with ARDS due to SARS-CoV-2 pneumonia under mechanical ventilation in intensive care unit.

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.

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)

Primary outcomes:
measure: The distribution of ventilation
timeFrame: Through study completion (up to 24 hours)
Secondary outcomes:
measure: Silent spaces
timeFrame: Through study completion (up to 24 hours)
measure: Respiratory system compliance
timeFrame: Through study completion (up to 24 hours)
measure: Oxygenation
timeFrame: Through study completion (up to 24 hours)
measure: Dead space ventilation ratio
timeFrame: Through study completion (up to 24 hours)
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University
name: Takeshi Yoshida, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: