- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327268
Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS
December 25, 2025 updated by: Ling Liu, Southeast University, China
Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS Patients With Mechanical Ventilation
Although the theoretical model of "cyclic on-off switching of pulmonary blood flow" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles.
The fundamental reason lies in the lack of pulmonary microcirculation monitoring technology capable of bedside, non-invasive, continuous operation with sufficient spatiotemporal resolution.
Nowadays, a novel 3D-EIT can perform real-time and non-invasive assessment of the distribution of pulmonary blood flow.
However, if 3D-EIT can help to identify "cyclic on-off switching of pulmonary blood flow" is still unclear.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ling liu Liu, PhD
- Phone Number: +86 83262550
- Email: liulingdoctor@126.com
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, School of Medicine, Southeast University
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Contact:
- yuan xueyan, MD
- Phone Number: +86 83262550
- Email: 18826401594@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Consecutive adult patients admitted to our ICU were screened for inclusion and exclusion criteria
Description
Inclusion Criteria:
- Adult patients with mechanical ventilation
- diagnosis of moderate to severe ARDS no more than 72 hours
Exclusion Criteria:
- Chronic respiratory diseases that required long-term oxygen therapy, such as pulmonary fibrosis or chronical obstructive pulmonary disease
- Contraindications to EIT (e.g., active implantable device, chest malformation, unstable spinal injuries or fractures, and open chest wounds)
- Undrained pneumothorax or pneumomediastinum,
- Hemodynamic instability
- Pregnancy
- Refusal by family or the attending physician to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
phase 1
patients ventilated with a tidal volume of 4ml/kg pbw
|
|
phase 2
patients ventilated with a tidal volume of 6ml/kg pbw
|
|
phase 3
patients ventilated with a tidal volume of 8ml/kg pbw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The percent of "Cyclic On-Off Switching"
Time Frame: 15min
|
"Cyclic On-Off Switching" was assessed by 3D-EIT
|
15min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
December 25, 2025
First Submitted That Met QC Criteria
December 25, 2025
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
December 25, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D-EIT perfusion
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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