Incidence and Clinical Characteristics of Pulmonary Hyper... | NCT05166759

Studies
Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland

NCT05166759

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Dec 22, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

ARDS

Interventions

Doppler ultrasound

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2021Actual

Primary Completion Date

Mar 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Dec 20, 2021

First Submission Date that Met QC Criteria

Dec 21, 2021

First Posted Date

Dec 22, 2021Actual

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

Dec 21, 2021

Last Update Posted Date

Dec 22, 2021Actual

Name	Class
Qinghai University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.

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

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler ultrasound	Device	Pulmonary artery pressure and right heart function will be assessed using Doppler ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland		20/11/2021-20/12/2022
ICU mortality ICU mortality	Mortality during treatment in ICU	20/11/2021-20/12/2022
28-days mortality rate	Mortality at 28 days of hospitalization	20/11/2021-20/12/2022

Secondary Outcomes

Measure	Description	Time Frame
Ventilator time	Ventilator time in ICU	20/11/2021-20/12/2022
Hospital length of stay	Total length of stay in hospital	20/11/2021-20/12/2022

Other Outcomes

Measure	Description	Time Frame
Right cardiac functionof Pulmonary Hypertension Secondary to ARDS in the Highland		20/11/2021-20/12/2022

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours

Exclusion Criteria:

Patients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too.

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chun Pan, MD	Contact	13814009925		panchun1982@gmail.com
Peng Zhu	Contact	18625195060		sqzhupeng@163.com

Overall Officials

Name	Affiliation	Role
Chun Pan, MD	Qinghai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of QingHai University	Recruiting	Xining	Qinghai		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37524522	Derived	Zhu P, Zhu J, Tong S, She X, Qi Z, Xu Q, Shi Z, Si L, Hou M, Gan G, Pan C. Clinical characteristics of patients with a risk of pulmonary artery hypertension secondary to ARDS in a high-altitude area. BMJ Open Respir Res. 2023 Jul;10(1):e001475. doi: 10.1136/bmjresp-2022-001475.

ID	Term
D014463	Ultrasonography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis