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RecruitingNCT06430554Updated Sep 3, 2026

Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability

An observational study in Respiratory Distress Syndrome, Positive-Pressure Respiration and Mechanical Ventilation, sponsored by Zhongda Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Zhongda Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability.

Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows:

Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team.

To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters.

EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%).

02

Conditions studied

  • Respiratory Distress Syndrome
  • Positive-Pressure Respiration
  • Mechanical Ventilation

Keywords

  • Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching.
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Intubated mechanically ventilated ARDS patients.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. age ≥85 years
  2. Pregnancy
  3. Severe hemodynamic instability (> 30% increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min)
  4. Clinically suspected elevated intracranial pressure (>18 mm Hg)
  5. Bronchopleural fistula
  6. Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  7. Severe hypernatremia (>170mmol/L)
  8. Re-admission of patients already enrolled in this study, or patients who are participating in other studies
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
05

What researchers measure

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

    Time frame: Through study completion (within 24 hours)

Secondary outcomes

  1. percentage of dead space

    corresponding to the ventilated but nonperfused pixels divided by the total number of pixels ventilated and/or perfused

    Time frame: Through study completion (within 24 hours)

  2. percentage of shunt

    corresponding to the perfused but nonventilated pixels divided by the total number of pixels ventilated and/or perfused

    Time frame: Through study completion (within 24 hours)

  3. Respiratory system compliance

    The compliance of respiratory system

    Time frame: Through study completion (within 24 hours)

  4. PaO2/FiO2 ratio

    PaO2/FiO2 ratio

    Time frame: Through study completion (within 24 hours)

06

Study locations

1 of 1 sites recruiting
  • Zhongda Hospital, Southeast University
    Nanjing, Jiangsu 210009, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06430554
Lead sponsor
Zhongda Hospital
Responsible party
Fengmei Guo (Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China, Zhongda Hospital) — Principal investigator
First posted
May 28, 2024
Start date
Jun 8, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 3, 2026

Study contacts

Fengmei Guo, PhD, MD
Contact
fmguo2022@163.com
+8613813841261
Zhiqian Zha, MM
Contact
15505083904@163.com
+8615505083904
Fengmei Guo, PhD, MD
study chair · Nanjing Zhongda Hospital, Southeast University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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