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NCT Number: NCT04473300

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

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.

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Key information

Conditions

Critical Illness ARDS Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. The distribution of ventilation

    Time frame: Through study completion (up to 24 hours)

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

Secondary outcomes

  1. Silent spaces

    Time frame: Through study completion (up to 24 hours)

    The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.

  2. Respiratory system compliance

    Time frame: Through study completion (up to 24 hours)

    Respiratory system compliance in PEEP 5 and 15.

  3. Oxygenation

    Time frame: Through study completion (up to 24 hours)

    Oxygenation in PEEP 5 and 15.

  4. Dead space ventilation ratio

    Time frame: Through study completion (up to 24 hours)

    Dead space ventilation ratio in PEEP 5 and 15.

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Collaborators

  • Hospital Rebagliati

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2020
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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