Critical IllnessNCT04473300
Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography
An observational study of Critical Illness and ARDS, run by Osaka University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ARDS
- How many people
- 43 participants
- Where
- 1 siteJapan
- Study dates
- 11 May 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with ARDS due to SARS-CoV-2 pneumonia under mechanical ventilation in intensive care unit.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, ARDS
- Keywords
- SARS-CoV-2, electrical impedance tomography, positive end expiratory pressure
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of ventilation
The distribution of ventilation measured by EIT at PEEP 5 and 15.
Measured: Through study completion (up to 24 hours)
Secondary outcomes (4)
Silent spaces
The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.
Measured: Through study completion (up to 24 hours)
Respiratory system compliance
Respiratory system compliance in PEEP 5 and 15.
Measured: Through study completion (up to 24 hours)
Oxygenation
Oxygenation in PEEP 5 and 15.
Measured: Through study completion (up to 24 hours)
Dead space ventilation ratio
Dead space ventilation ratio in PEEP 5 and 15.
Measured: Through study completion (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start11 May 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Rebagliati
- Responsible party
- Sponsor
- Investigators
- Takeshi Yoshida, M.D., Ph.D., Principal investigator, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473300
- Sponsor's protocol ID
- ASPEIT
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04473300
- Acronym / sponsor ID
- ASPEIT
- Conditions
- Critical Illness, ARDS
- Keywords
- SARS-CoV-2, electrical impedance tomography, positive end expiratory pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Hospital Rebagliati
- Study start
- 11 May 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ARDS due to SARS-CoV-2 pneumonia under mechanical ventilation in intensive care unit.
Key inclusion criteria (5 listed)
- Patients with positive SARS-CoV-2 infection＊
- Patients with ARDS under mechanical ventilation＊＊
- Patients ≧ 18 years old
Key exclusion criteria (8 listed)
- Contraindication for EIT monitoring
- Home mechanical ventilation before inclusion
- Pregnancy
- DNR (do-not-resuscitate)
- Increased intracranial pressure (> 18 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Silent spaces
Time frame: Through study completion (up to 24 hours)
Respiratory system compliance
Time frame: Through study completion (up to 24 hours)
Oxygenation
Time frame: Through study completion (up to 24 hours)
Dead space ventilation ratio
Time frame: Through study completion (up to 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Yoshida, M.D., Ph.D. principal investigator
Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and ARDS, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distribution of ventilation (time frame: Through study completion (up to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.