NCT04322851

Brief Summary

The purpose of this study is to evaluate that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 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

First Submitted

Initial submission to the registry

February 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

February 26, 2020

Last Update Submit

February 1, 2023

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Re-intubation rate

    within 72 hours from initial extubation

Study Arms (2)

B-line positive

Diagnostic Test: Lung ultrasound

B-line negative

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasoundDIAGNOSTIC_TEST

Lung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure

B-line negativeB-line positive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who are on mechanical ventilation due to acute heart failure

You may qualify if:

  • mechanical ventilation due to acute heart failure

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Minseok Kim

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minseok Kim

CONTACT

(82-2)-3010-3948msk@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 26, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

February 2, 2023

Record last verified: 2023-02

Locations

KR(1)