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

NCT07327268 | Not Yet Recruiting

• 1 other identifier: 3D-EIT perfusion
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The percent of "Cyclic On-Off Switching"

  "Cyclic On-Off Switching" was assessed by 3D-EIT

  15min

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients admitted to our ICU were screened for inclusion and exclusion criteria

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

ling liu Liu, PhD

CONTACT

+86 83262550; liulingdoctor@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CN (1)