Electrical Impedance TomographyNCT05389735
Evaluation of Postoperative Ventilation Distribution With Electrical Impedance Tomography
An observational study of Electrical Impedance Tomography, run by Osaka University at 1 site in Japan.
Trial summary
Postoperative patients require respiratory management . It is known that the intrapulmonary ventilation distribution becomes uneven due to dorsal atelectasis and ventral hyperinflation during mechanical ventilation management, but the incidence in postoperative patients is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrical Impedance Tomography
- How many people
- 130 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2021to 30 Sep 2022
- 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: postoperative patients
Who may be able to join
None listed.
Who cannot join
- the EIT belt is worn Patients with unstable spine or pelvis due to fractures, etc. Patients with implantable defibrillation and implantable pacemaker Patients with skin lesions such as blisters between the 4th and 5th intercostal spaces where
- Patients with DNR (do-not-resuscitate)
- Patients undergoing home ventilator management before surgery
- Preoperative, hypocardiac function patients (echocardiography shows left ventricular ejection fraction of 40% or less, or NYHA III degree or more +)
- Patients with a ventricular assist device
- Patients with extracorporeal membrane oxygenation (VV or VA)
- History of neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Osaka
Hirofumi Iwata, M.D., 0668793133, hiwata@hp-icu.med.osaka-u.ac.jp
About this study
Official title: Evaluation of Ventilation Distribution With Electrical Impedance Tomography in Mechanically Ventilated Patients After Surgery: a Prospective Observational Study
Postoperative patients require respiratory management . It is known that the intrapulmonary ventilation distribution becomes uneven due to dorsal atelectasis and ventral hyperinflation during mechanical ventilation management, but the incidence in postoperative patients is unknown. EIT is a device that can monitor the ventilation distribution in the lungs over time without being exposed to the bedside. Therefore, for patients at risk of postoperative respiratory complications, use EIT to 1) evaluate the pulmonary ventilation distribution during postoperative ventilation management, 2) pulmonary ventilation distribution and postoperative respiratory organs. The purpose of this study is to clarify the relationship with the severity of complications.
A prospective observational study to investigate the relationship between ventilation distribution and prognosis using EIT in patients undergoing mechanical ventilation after adult surgery.
- Conditions
- Electrical Impedance Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score
Dorsal fraction of ventilation(%):The dorsal fraction of ventilation is calculated as the sum of all pixel values in the dorsal half of the EIT image over the sum of all pixel values from the EIT image
Postoperative pulmonary complications score(0-5):Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5, with grade zero representing absence of complications, grades 1 to 4 representing increasing (worsening) levels of complications, and grade 5 representing death before hospital discharge.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Oct 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical Impedance TomographyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Nihon Kohden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389735
- Sponsor's protocol ID
- hi38655072
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ventilation Distribution With Electrical Impedance Tomography in Mechanically Ventilated Patients After Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05389735
- Acronym / sponsor ID
- hi38655072
- Conditions
- Electrical Impedance Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Nihon Kohden
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 25 May 2022 (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.
Postoperative patients require respiratory management . It is known that the intrapulmonary ventilation distribution becomes uneven due to dorsal atelectasis and ventral hyperinflation during mechanical ventilation management, but the incidence in postoperative patients is unknown. EIT is a device that can monitor the ventilation distribution in the lungs over time without being exposed to the bedside. Therefore, for patients at risk of postoperative respiratory complications, use EIT to 1) evaluate the pulmonary ventilation distribution during postoperative ventilation management, 2) pulmonary ventilation distribution and postoperative respiratory organs. The purpose of this study is to clarify the relationship with the severity of complications.
A prospective observational study to investigate the relationship between ventilation distribution and prognosis using EIT in patients undergoing mechanical ventilation after adult surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- postoperative patients
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- the EIT belt is worn Patients with unstable spine or pelvis due to fractures, etc. Patients with implantable defibrillation and implantable pacemaker Patients with skin lesions such as blisters between the 4th and 5th intercostal spaces where
- Patients with DNR (do-not-resuscitate)
- Patients undergoing home ventilator management before surgery
- Preoperative, hypocardiac function patients (echocardiography shows left ventricular ejection fraction of 40% or less, or NYHA III degree or more +)
- Patients with a ventricular assist device
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
Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score
Time frame: up to 12 weeks
Dorsal fraction of ventilation(%):The dorsal fraction of ventilation is calculated as the sum of all pixel values in the dorsal half of the EIT image over the sum of all pixel values from the EIT image Postoperative pulmonary complications score(0-5):Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5, with grade zero representing absence of complications, grades 1 to 4 representing increasing (worsening) levels of complications, and grade 5 representing death before hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Homeostasis
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.
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Osaka, Japan
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 Electrical Impedance Tomography, 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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score (time frame: up to 12 weeks). 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 25 May 2022.