The Physiological Effect of RCexp on Ventilation/Perfusio... | NCT06919484

Studies
The Physiological Effect of RCexp on Ventilation/Perfusion Distribution

NCT06919484

Sponsor

Southeast University, China

Status

Recruiting

Last Update Posted

Nov 26, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome
Mechanical Ventilation

Interventions

RCexp

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2025Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 2, 2025

First Submission Date that Met QC Criteria

Apr 2, 2025

First Posted Date

Apr 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2025

Last Update Posted Date

Nov 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

28 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mechanically ventilated patients with ARDS			Other: RCexp

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RCexp	Other	patients received different RCexp	mechanically ventilated patients with ARDS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in ventilation/perfusion mismatch	ventilation/perfusion mismatch is measured by EIT	4 hours

Secondary Outcomes

Measure	Description	Time Frame
Difference in dead space	dead space is measured by EIT	4 hours
Difference in shunt	shunt is measured by EIT	4 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients with ARDS receiving mechanical ventilation no more than 72 hours

Exclusion Criteria:

age <18 years old
patient undergoing legal protection
contra-indications to EIT (e. g. severe chest trauma or wounds)
pneumothorax
patient undergoing ECMO
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yuan xue yan, MD	Contact	+86-15901599659		18826401594@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda Hospital, School of Medicine, Southeast University	Recruiting	Nanjing	Jiangsu	210009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided