CClinicalTrials.gg
Status unknownNCT03574233Updated Feb 12, 2019

Ultrasonography Guided Weaning Protocol Development to Predict Successful Weaning

An observational study in Mechanical Ventilation, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Prolonged mechanical ventilation is associated with higher ventilator-associated pneumonia and ventilator-associated lung injury, longer intensive care unit and hospital days, increased mortality, and higher medical costs. However, some patients are difficult to wean from invasive mechanical ventilation. Typically, the difficulty in transitioning patients to spontaneous breathing may be categorized as simple transition, difficult transition, and prolonged transition.

There are a lot of predictors for weaning failure such as cardiac dysfunction, increased respiratory rate, diaphragm dysfunction, rapid shallow breathing index and so on. However, weaning failure involves complicated mechanisms that are not solved by one cause. Recently, P. Mayo published a review paper on ultrasonography evaluation during the weaning process. The investigators need to pay attention to this paper. While lots of previous predictors cannot explain the reason, ultrasound evaluation is a process of finding the cause as well as prediction for weaning failure. However, The investigators need a more practical and standardized ultrasound protocols for how to wean invasive mechanical ventilation. "Ultrasonographic mechanical weaning protocol" should not comprise just one indicator, but include various indicators such as upper airway stenosis, heart function, the status of the lung and pleura, diaphragmatic function, Etc. This integrated ultrasound protocol will help in successful weaning of invasive mechanical ventilation.

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Conditions studied

  • Mechanical Ventilation
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Mechanically ventilation participants in a mixed intensive care unit

Inclusion criteria

  1. Invasive mechanical ventilation > 24 hours
  2. Eligibility to weaning from mechanical ventilation

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years old
  2. Severe skin lesions or infections that cannot perform ultrasound
  3. Severe subcutaneous emphysema that cannot perform ultrasound
  4. Patients who completed "Do-not-resuscitation" consents
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients who are ready to wean ventilator off
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What researchers measure

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

    Time frame: within 48 hours

Secondary outcomes

  1. A) In-ICU mortality

    Time frame: 90 days after Ultrasonography

  2. B) In-hospital mortality

    Time frame: 90 days after Ultrasonography

  3. C) Ventilator free day

    Time frame: 90 days after Ultrasonography

  4. D) ICU free day

    Time frame: 90 days after Ultrasonography

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Study locations

1 of 1 sites recruiting
  • Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03574233
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 29, 2018
Start date
Mar 2019 (estimated)
Primary completion
May 30, 2019 (estimated)
Completion
May 30, 2019 (estimated)
Last update
Feb 12, 2019

Study contacts

Kyungsoo Chung, MD
Contact
CHUNGKS@yuhs.ac
82-2-2228-2270

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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