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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473300
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : July 1, 2021
Sponsor:
Collaborator:
Hospital Rebagliati
Information provided by (Responsible Party):
Osaka University

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study
Actual Study Start Date : May 11, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with ARDS due to SARS-CoV-2 pneumonia under mechanical ventilation in intensive care unit.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473300


Locations
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Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Osaka University
Hospital Rebagliati
Investigators
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Principal Investigator: Takeshi Yoshida, M.D., Ph.D. Osaka University
More Information
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Responsible Party: Osaka University
ClinicalTrials.gov Identifier: NCT04473300    
Other Study ID Numbers: ASPEIT
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osaka University:
SARS-CoV-2
electrical impedance tomography
positive end expiratory pressure
Additional relevant MeSH terms:
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Pneumonia
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Critical Illness
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Disease Attributes
Pathologic Processes