Electrical Impedance Tomography-Based Prognostic Model fo... | NCT06967207

Studies
Electrical Impedance Tomography-Based Prognostic Model for ARDS

NCT06967207

Sponsor

XiaoJing Zou,MD

Status

Recruiting

Last Update Posted

May 13, 2025Actual

Enrollment

625Estimated

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome (ARDS)
Ventilator-induced Lung Injury

Interventions

Not applicable- observational study

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

May 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

Apr 15, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Apr 22, 2025

First Submission Date that Met QC Criteria

May 10, 2025

First Posted Date

May 13, 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

May 10, 2025

Last Update Posted Date

May 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

XiaoJing Zou,MD, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

XiaoJing Zou,MDOTHER

Collaborators

Not provided

Description Module

Brief Summary

This multicenter, prospective, observational study aims to develop and validate an EIT-based prognostic model for ARDS. By focusing on the pathophysiological characteristics of ARDS and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and heterogeneity, enabling risk stratification and guiding individualized treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

625Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARDS Patients for Training cohort		Training cohort	Other: Not applicable- observational study
ARDS Patients for Validation cohort		Validation cohort	Other: Not applicable- observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not applicable- observational study	Other	Not applicable- observational study	ARDS Patients for Training cohort ARDS Patients for Validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day mortality rate		From date of study enrollment (Day 0) until Day 28

Secondary Outcomes

Measure	Description	Time Frame
ICU mortality rate		From ICU admission to discharge, up to 24 weeks
60-day all-cause mortality rate		60 days post-enrollment
90-day all-cause mortality rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the new 2023 ARDS global definition;
Age 18-80 years

Exclusion Criteria:

Expected death within 24 hours of screening;
Metastatic cancer (active malignancy with distant metastases);
Severe psychiatric disorders;
Pregnancy or postpartum status;
Pneumothorax or moderate to large pleural effusion without adequate drainage;
Chronic respiratory failure;
Patients with pulmonary embolism or pulmonary hypertension;
Heart failure patients: EF <50% or NYHA class III or IV;
Patient/family refusal to participate;
Participation in another interventional trial within 3 months prior to enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

This is a prospective, multicenter, observational cohort study that will enroll adult patients (aged 18-80 years) diagnosed with acute respiratory distress syndrome (ARDS) per the new 2023 ARDS global definition.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaojing Zou Zou	Contact	84+13995518630		249126734@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical Care Medicine, Guangdong Provincial People's Hospital	Recruiting	Guangzhou	Guangdong		China

IPD Sharing Statement Module

Plan to Share IPD

Yes

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
D055397	Ventilator-Induced Lung Injury

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D055370	Lung Injury

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Peripheral whole blood samples will be collected and processed to isolate plasma, serum, and peripheral blood mononuclear cells (PBMCs). Processed samples (plasma, serum, PBMCs) will be stored at -80°C for future research. No DNA will be intentionally extracted or retained.