NCT06919484

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

April 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

April 2, 2025

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in ventilation/perfusion mismatch

    ventilation/perfusion mismatch is measured by EIT

    4 hours

Secondary Outcomes (2)

  • Difference in dead space

    4 hours

  • Difference in shunt

    4 hours

Study Arms (1)

mechanically ventilated patients with ARDS

Other: RCexp

Interventions

RCexpOTHER

patients received different RCexp

mechanically ventilated patients with ARDS

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

yuan xue yan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 2, 2025

First Posted

April 9, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations