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

NCT04473300 | Completed

• 1 other identifier: ASPEIT
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; ARDS

Keywords

SARS-CoV-2; electrical impedance tomography; positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

• The distribution of ventilation

  The distribution of ventilation measured by EIT at PEEP 5 and 15.

  Through study completion (up to 24 hours)

Secondary Outcomes (4)

• Silent spaces

  Through study completion (up to 24 hours)

• Respiratory system compliance

  Through study completion (up to 24 hours)

• Oxygenation

  Through study completion (up to 24 hours)

• Dead space ventilation ratio

  Through study completion (up to 24 hours)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• Pregnancy
• DNR (do-not-resuscitate)
• Increased intracranial pressure (\> 18 mmHg)

Sponsors & Collaborators

• Osaka University: lead
• Hospital Rebagliati: collaborator

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Takeshi Yoshida, M.D., Ph.D.

  Osaka University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 16, 2020
• Study Start: May 11, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 1, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)