Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS

NCT ID: NCT07327268

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS (Acute Respiratory Distress Syndrome) Electrical Impedance Tomography (EIT) Pulmonary Perfusion

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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phase 1

patients ventilated with a tidal volume of 4ml/kg pbw

No interventions assigned to this group

phase 2

patients ventilated with a tidal volume of 6ml/kg pbw

No interventions assigned to this group

phase 3

patients ventilated with a tidal volume of 8ml/kg pbw

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adult patients with mechanical ventilation
2. diagnosis of moderate to severe ARDS no more than 72 hours

Exclusion Criteria

1. Chronic respiratory diseases that required long-term oxygen therapy, such as pulmonary fibrosis or chronical obstructive pulmonary disease
2. Contraindications to EIT (e.g., active implantable device, chest malformation, unstable spinal injuries or fractures, and open chest wounds)
3. Undrained pneumothorax or pneumomediastinum,
4. Hemodynamic instability
5. Pregnancy
6. Refusal by family or the attending physician to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Ling Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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ling liu Liu, PhD

Role: CONTACT

+86 83262550

Facility Contacts

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yuan xueyan, MD

Role: primary

+86 83262550

Other Identifiers

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3D-EIT perfusion

Identifier Type: -

Identifier Source: org_study_id

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