Mechanical VentilationNCT03574233
Ultrasonography Guided Weaning Protocol Development to Predict Successful Weaning
An observational study of Mechanical Ventilation, run by Yonsei University at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2019to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilation participants in a mixed intensive care unit
Who may be able to join
- Invasive mechanical ventilation > 24 hours
- Eligibility to weaning from mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul, 03722
Kyungsoo Chung, MD, 82-2-2228-2270, CHUNGKS@yuhs.ac
About this study
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.
- Conditions
- Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who are ready to wean ventilator off | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 48 hours
Secondary outcomes (4)
A) In-ICU mortality
Measured: 90 days after Ultrasonography
B) In-hospital mortality
Measured: 90 days after Ultrasonography
C) Ventilator free day
Measured: 90 days after Ultrasonography
D) ICU free day
Measured: 90 days after Ultrasonography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study startMar 2019 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574233
- Sponsor's protocol ID
- 4-2018-0357
- Status last verified
- Feb 2019
- First submitted
- 3 Jun 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Guided Weaning Protocol Development to Predict Successful Weaning
- ClinicalTrials.gov ID
- NCT03574233
- Acronym / sponsor ID
- 4-2018-0357
- Conditions
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who are ready to wean ventilator off | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilation participants in a mixed intensive care unit
Key inclusion criteria (2 listed)
- Invasive mechanical ventilation > 24 hours
- Eligibility to weaning from mechanical ventilation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigation of ultrasound indices associated with the success or failure of mechanical ventilation weaning
Time frame: within 48 hours
* 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
4 secondary outcomes
A) In-ICU mortality
Time frame: 90 days after Ultrasonography
B) In-hospital mortality
Time frame: 90 days after Ultrasonography
C) Ventilator free day
Time frame: 90 days after Ultrasonography
D) ICU free day
Time frame: 90 days after Ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyungsoo Chung, MD (82-2-2228-2270, CHUNGKS@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of ultrasound indices associated with the success or failure of mechanical ventilation weaning (time frame: within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.