Clinical Study of Titrating PEEP of Different Methods on... | NCT03845556

Studies
Clinical Study of Titrating PEEP of Different Methods on Right Heart Function

NCT03845556

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Feb 19, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

ARDS, Human

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

Feb 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

Aug 4, 2018Actual

Primary Completion Date

Mar 30, 2019Estimated

Completion Date

Mar 30, 2019Estimated

First Submitted Date

Oct 11, 2018

First Submission Date that Met QC Criteria

Feb 17, 2019

First Posted Date

Feb 19, 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

Feb 17, 2019

Last Update Posted Date

Feb 19, 2019Actual

Name	Class
Zhongda Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients .

Detailed Description

30 patients who diagnosed as ARDS were included in this study.Then set PEEP with respectively ARDS net 、EIT and Esophageal Pressure in Breathing Machine . Recorded diameter of right and left ventricular TAM TAPSE pulmonary artery pressure.Objective to evaluate the correlation between the level of PEEP in three methods and the right heart function and pulmonary artery pressure in ARDS patients .

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 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the function of right heart and pulmonary artery pressure	Systolic Pulmonary Artery Pressure TAPSE or Tricuspid Annular Motion orTricuspid annular plane systolic excursion or right ventricular diameter or right left ventricular diameter ratio in diffrient PEEP	2018.4-2019.3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to ICU diagnosed of modecate to severe ARDS (Berlin criteria)
Patients age between 18 years old and 80 years

Exclusion Criteria:

Patients with chronic respiratory diseases such as COPD.
Ventilated because of oesophageal surgery in the previous 12months.
Patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion.
Oesophageal bleeding in previous 30 days history of oesophageal varices.
Facial trauma and surgery.

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

Population admitted to ICU of Zhongda hospital，diagnosed of medium or serious ARDS。

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dutong Yue, Dr	Contact	15051887681		1475008526@qq.com
GuoFeng Mei, Dr	Contact	13813841261		13813841261@139.com

Overall Officials

Name	Affiliation	Role
Chun Pan, Dr	southeast university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda Hospital	Recruiting	Nanjing	Jiangsu	210009	China

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