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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; ARDS

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with ARDS due to SARS-CoV-2 pneumonia under mechanical ventilation in intensive care unit.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Osaka University
• Collaborators: Hospital Rebagliati

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2020
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; electrical impedance tomography; positive end expiratory pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Pneumonia; Critical Illness; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ASPEIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No