Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability

NCT06430554 | Recruiting

• 1 other identifier: 2024ZDSYLL044-P01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.

Conditions

Respiratory Distress Syndrome; Positive-Pressure Respiration; Mechanical Ventilation

Keywords

Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching.

Outcome Measures

Primary Outcomes (1)

• Ventilation-perfusion matching (V/Q match%)

  corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused

  Through study completion (within 24 hours)

Secondary Outcomes (4)

• percentage of dead space

  Through study completion (within 24 hours)

• percentage of shunt

  Through study completion (within 24 hours)

• Respiratory system compliance

  Through study completion (within 24 hours)

• PaO2/FiO2 ratio

  Through study completion (within 24 hours)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intubated mechanically ventilated ARDS patients.

You may qualify if:

• age ≥18 years
• Moderate-to-severe ARDS as per the 2023 ESICM definition
• Undergoing invasive mechanical ventilation
• Planned prone position based on the attending physicians' decisions
• Signed informed consent

You may not qualify if:

• age ≥85 years
• Pregnancy
• Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
• Clinically suspected elevated intracranial pressure (\>18 mm Hg)
• Bronchopleural fistula
• Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
• Severe hypernatremia (\>170mmol/L)
• Re-admission of patients already enrolled in this study, or patients who are participating in other studies

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fengmei Guo, PhD, MD

  Nanjing Zhongda Hospital, Southeast University

  STUDY CHAIR

Central Study Contacts

Fengmei Guo, PhD, MD

CONTACT

+8613813841261; fmguo2022@163.com

Zhiqian Zha, MM

CONTACT

+8615505083904; 15505083904@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: June 8, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)