NCT03920189

Brief Summary

The purpose of this study is to assess the left diastolic function at different levels of in patients affected by the acute respiratory distress syndrome (ARDS)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

April 16, 2019

Last Update Submit

June 23, 2022

Conditions

Acute Respiratory Distress SyndromeMechanical VentilationEchocardiographic Ultrasound

Outcome Measures

Primary Outcomes (1)

  • echocardiographic ultrasound

    left ventricular dyastolic function

    day 1

Interventions

echocariographic ultrasoundDIAGNOSTIC_TEST

left ventricular diastolic function description

Eligibility Criteria

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

consecutive ARDS patients

You may qualify if:

  • All patients aged 18 or older and with a recent (\<48h) diagnosis of ARDS, undergoing invasive mechanical ventilation

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST-Santi Paolo e Carlo, San Paolo Hospital

Milan, 20142, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 18, 2019

Study Start

September 1, 2018

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)