Acute Respiratory Distress SyndromeNCT06919484
The Physiological Effect of RCexp on Ventilation/Perfusion Distribution
An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by Southeast University, China at 1 site in China.
Trial summary
With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Mechanical Ventilation
- What is being tested?
- RCexp
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Dec 2026
- How long will I take part?
- 28 Days
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O) 2. undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset
Who may be able to join
- adult patients with ARDS receiving mechanical ventilation no more than 72 hours
Who cannot join
- age <18 years old
- patient undergoing legal protection
- contra-indications to EIT (e. g. severe chest trauma or wounds)
- pneumothorax
- patient undergoing ECMO
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
yan xue yuan, 032-83262550, 18826401594@163.com
About this study
Official title: The Physiological Effect of RCexp on Ventilation/Perfusion Distribution in Patients With ARDS
With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.
Read the detailed description
With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.
- Being tested
- RCexp
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCexpOther
patients received different RCexp
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated patients with ARDS | Not described Receives: Other: RCexp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ventilation/perfusion mismatch
ventilation/perfusion mismatch is measured by EIT
Measured: 4 hours
Secondary outcomes (2)
Difference in dead space
dead space is measured by EIT
Measured: 4 hours
Difference in shunt
shunt is measured by EIT
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 Nov 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919484
- Sponsor's protocol ID
- RCexp_ventilation/perfusion
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Effect of RCexp on Ventilation/Perfusion Distribution in Patients With ARDS
- ClinicalTrials.gov ID
- NCT06919484
- Acronym / sponsor ID
- RCexp_ventilation/perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.
Detailed description
With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated patients with ARDS | – | Other: RCexp |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O) 2. undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset
Key inclusion criteria (1 listed)
- adult patients with ARDS receiving mechanical ventilation no more than 72 hours
Key exclusion criteria (6 listed)
- age <18 years old
- patient undergoing legal protection
- contra-indications to EIT (e. g. severe chest trauma or wounds)
- pneumothorax
- patient undergoing ECMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RCexppatients received different RCexp | Other | mechanically ventilated patients with ARDS |
Primary outcome
Difference in ventilation/perfusion mismatch
Time frame: 4 hours
ventilation/perfusion mismatch is measured by EIT
2 secondary outcomes
Difference in dead space
Time frame: 4 hours
Difference in shunt
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by Southeast University, China 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 1 inclusion and 6 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 26 Nov 2025. 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 yuan xue yan, MD (+86-15901599659, 18826401594@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in ventilation/perfusion mismatch (time frame: 4 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 26 Nov 2025.