Pulmonary VentilationNCT05105932
The Study of Regional Lung Ventilation-perfusion by EIT
An observational study of Pulmonary Ventilation and Pulmonary Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective observational trial. The purpose of this study is to explore the feasibility of EIT monitoring pulmonary blood flow and the consistency and difference between EIT monitoring pulmonary local ventilation blood flow and SPECT and CTPA monitoring methods Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Ventilation, Pulmonary Perfusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jun 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who need CTPA examination in the Department of nuclear medicine / radiology of Peking Union Medical College Hospital
Who may be able to join
- Admission to ICU was less than 72 hours;
- Age ≥ 18 years old and ≤ 80 years old;
- Volunteer to participate after communicating with patients' family members;
Who cannot join
- The patients with heart implants could not be monitored by EIT;
- Patients or their families refused to participate in the study;
- Hypernatremia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Yun Long, 13911608699, ly_icu@aliyun.com
Siyi Yuan, 15201518815, yuansiyizqh@163.com
About this study
This is a prospective observational trial. The purpose of this study is to explore the feasibility of EIT monitoring pulmonary blood flow and the consistency and difference between EIT monitoring pulmonary local ventilation blood flow and SPECT and CTPA monitoring methods
- Conditions
- Pulmonary Ventilation, Pulmonary Perfusion
- Keywords
- EIT, pulmonary perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EIT group | patients went through EIT detection | |
| CTPA group | patients went through CTPA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional pulmonary perfusion by EIT
Using EIT to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio
Measured: 1 Day
Regional pulmonary perfusion by CTPA
Using CTPA to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio
Measured: 1 Day
Secondary outcomes (1)
Regional pulmonary ventilation index by EIT
Regional pulmonary ventilation index by EIT, including GI: global inhomogeneity CoV: center of ventilation, ROI: region of interest
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jan 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105932
- Sponsor's protocol ID
- PUMCH-EIT-PE
- Status last verified
- Oct 2021
- First submitted
- 28 Jan 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Regional Lung Ventilation-perfusion by EIT
- ClinicalTrials.gov ID
- NCT05105932
- Acronym / sponsor ID
- PUMCH-EIT-PE
- Conditions
- Pulmonary Ventilation, Pulmonary Perfusion
- Keywords
- EIT, pulmonary perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Nov 2021 (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.
This is a prospective observational trial. The purpose of this study is to explore the feasibility of EIT monitoring pulmonary blood flow and the consistency and difference between EIT monitoring pulmonary local ventilation blood flow and SPECT and CTPA monitoring methods
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT group | – | –patients went through EIT detection |
| CTPA group | – | –patients went through CTPA detection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need CTPA examination in the Department of nuclear medicine / radiology of Peking Union Medical College Hospital
Key inclusion criteria (3 listed)
- Admission to ICU was less than 72 hours;
- Age ≥ 18 years old and ≤ 80 years old;
- Volunteer to participate after communicating with patients' family members;
Key exclusion criteria (3 listed)
- The patients with heart implants could not be monitored by EIT;
- Patients or their families refused to participate in the study;
- Hypernatremia
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
Regional pulmonary perfusion by EIT
Time frame: 1 Day
Using EIT to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio
Regional pulmonary perfusion by CTPA
Time frame: 1 Day
Using CTPA to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio
1 secondary outcome
Regional pulmonary ventilation index by EIT
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Yun Long study director
Peking Union Medical College Hospital
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 Pulmonary Ventilation and Pulmonary Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 3 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 3 Nov 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 China. 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?
Contact Yun Long (13911608699, ly_icu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional pulmonary perfusion by EIT (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 3 Nov 2021.