NCT03574233

Brief Summary

The investigators aimed to develop integrated ultrasound guided mechanical weaning protocol in critically ill patients. The analysis will be taken (1) just before the spontaneous breathing trial in enrolled patients with mechanical ventilation and (2) in patients with tracheostomy who fail ventilator off.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

June 3, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

June 3, 2018

Last Update Submit

February 11, 2019

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Investigation of ultrasound indices associated with the success or failure of mechanical ventilation weaning

    * Weaning success: stable without mechanical ventilator support during more than 48 hours * Weaning failure: unstable without mechanical ventilator support within 48 hours A) Type I respiratory failure: high flow oxygen support B) Type II respiratory failure: non-invasive ventilatory support C) Reintubation

    within 48 hours

Secondary Outcomes (4)

  • A) In-ICU mortality

    90 days after Ultrasonography

  • B) In-hospital mortality

    90 days after Ultrasonography

  • C) Ventilator free day

    90 days after Ultrasonography

  • D) ICU free day

    90 days after Ultrasonography

Study Arms (1)

patients who are ready to wean ventilator off

Eligibility Criteria

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

Mechanically ventilation participants in a mixed intensive care unit

You may qualify if:

  • Invasive mechanical ventilation \> 24 hours
  • Eligibility to weaning from mechanical ventilation

You may not qualify if:

  • Age \< 18 years old
  • Severe skin lesions or infections that cannot perform ultrasound
  • Severe subcutaneous emphysema that cannot perform ultrasound
  • Patients who completed "Do-not-resuscitation" consents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Central Study Contacts

Kyungsoo Chung, MD

CONTACT

82-2-2228-2270CHUNGKS@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2018

First Posted

June 29, 2018

Study Start

March 1, 2019

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

KR(1)