Definition of ARDS in Qinghai Province: Verification of B... | NCT04199650

Studies
Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria

NCT04199650

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Dec 16, 2019Actual

Enrollment

253Estimated

Phase

Not provided

Conditions

ARDS
High Altitude

Interventions

Not provided

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

Dec 2019

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

Apr 1, 2019Actual

Primary Completion Date

Jan 30, 2020Estimated

Completion Date

Aug 30, 2020Estimated

First Submitted Date

Dec 5, 2019

First Submission Date that Met QC Criteria

Dec 13, 2019

First Posted Date

Dec 16, 2019Actual

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 13, 2019

Last Update Posted Date

Dec 16, 2019Actual

Name	Class
Affiliated Hospital of Qinghai University	OTHER

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

The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).

Detailed Description

This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg < PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg < PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.

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

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

253Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild ARDS		153mmHg\
Moderate ARDS		76mmHg\
Severe ARDS		PaO2/FiO2≤76mmHg

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICU mortality	Mortality during treatment in ICU	up to 24 weeks
28-days mortality rate	Mortality at 28 days of hospitalization	28 days after discharge

Secondary Outcomes

Measure	Description	Time Frame
Ventilator Free time	Ventilator time not used in ICU	up to 24 weeks
Ventilator time	Ventilator time in ICU	up to 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age
Meet the diagnostic criteria of ARDS
Receive invasive mechanical ventilation

Exclusion Criteria:

Receive a large number of hormone shock therapy in a short period of time
Death within a short period of time (< 24 h) after mechanical ventilation
No chest imaging data
Data missing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From January 2018 to December 2018, patients admitted to the department of critical care, affiliated hospital of qinghai university were diagnosed with acute respiratory distress syndrome according to Berlin Definition.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gan Guifen, Bachelor	Contact	15897083336		xzhd1991@163.com
Pan Chun, Doctor	Contact	13814009925		panchun1982@gmail.com

Overall Officials

Name	Affiliation	Role
Liu Xiaoqin, Bachelor	Affiliated Hospital of Qinghai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ChunPan	Recruiting	Nanjing	Jiangsu	210000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35280910	Derived	Liu X, Pan C, Si L, Tong S, Niu Y, Qiu H, Gan G. Definition of Acute Respiratory Distress Syndrome on the Plateau of Xining, Qinghai: A Verification of the Berlin Definition Altitude-PaO2/FiO2-Corrected Criteria. Front Med (Lausanne). 2022 Feb 23;9:648835. doi: 10.3389/fmed.2022.648835. eCollection 2022.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases