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Respiratory Distress SyndromeNCT06430554

Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability

An observational study of Respiratory Distress Syndrome and Positive-Pressure Respiration, run by Zhongda Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 85 years
How many people
40 participants
Where
1 siteChina
Study dates
8 Jun 2024to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Intubated mechanically ventilated ARDS patients.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fengmei Guo, PhD, MD contact

+8613813841261

fmguo2022@163.com

Zhiqian Zha, MM contact

+8615505083904

15505083904@163.com

China1 site, 1 recruiting
  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

    Fengmei Guo, Ph.D, +8613813841261, fmguo2022@163.com

    Recruiting

Other trials in China

About this study

Official title: Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients

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%).

Keywords
Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching.
Medical subject headings
Respiratory Distress Syndrome, Respiratory Aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion (within 24 hours)

Secondary outcomes (4)
  1. percentage of dead space

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

    Measured: 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

    Measured: Through study completion (within 24 hours)

  3. Respiratory system compliance

    The compliance of respiratory system

    Measured: Through study completion (within 24 hours)

  4. PaO2/FiO2 ratio

    PaO2/FiO2 ratio

    Measured: Through study completion (within 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start8 Jun 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06430554
Sponsor's protocol ID
2024ZDSYLL044-P01
Status last verified
Aug 2026
First submitted
21 May 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Distress Syndrome and Positive-Pressure Respiration, run by Zhongda Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fengmei Guo, PhD, MD (+8613813841261, fmguo2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilation-perfusion matching (V/Q match%) (time frame: Through study completion (within 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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