NCT03845556

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

October 11, 2018

Last Update Submit

February 17, 2019

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Chun Pan, Dr

    southeast university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dutong Yue, Dr

CONTACT

150518876811475008526@qq.com

GuoFeng Mei, Dr

CONTACT

1381384126113813841261@139.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 11, 2018

First Posted

February 19, 2019

Study Start

August 4, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

CN(1)