Critically IllNCT04711590
Microcirculation in Spontaneous Breathing Trial
An observational study of Critically Ill, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Microcirculation examination
- How many people
- 59 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2019to 30 Sep 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients who are ready for weaning ventilator support and receive spontaneous breathing trial.
Who may be able to join
- critically ill patients received ventilator longer than 12 hours
- ready for spontaneous breathing trial
- GCS coma score equal or higher than 8
Who cannot join
- aged less than 20 years
- patient with tracheostomy
- patient and patients' relatives are non-native speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Change of Microcirculation After Spontaneous Breathing Trial and Ventilator Weaning
Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Hemodynamic stability and physical reserve are important indicators as well. Microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. We hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. Thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). The microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.
- Conditions
- Critically Ill
- Being tested
- Microcirculation examination
- Keywords
- ventilator, weaning, microcirculation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcirculation examinationOther
Sublingual microcirculation images were recorded using an incident dark-field video microscope
| Study group | Role | What they receive |
|---|---|---|
| Successful extubation | The patients pass the spontaneous breathing trial and are successful extubated without reintubation within 72 hours. . Receives: Other: Microcirculation examination | |
| Failed extubation | The patients pass the spontaneous breathing trial and are successful extubated with reintubation within 72 hours. . Receives: Other: Microcirculation examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial total vessel density
Total vessel density measured by Cytocam before and after spontaneous breathing trial
Measured: 0 hour
Change of total vessel density
The difference between the total vessel density measure by Cytocam before and after spontaneous breathing trial
Measured: baseline and 1 hour
Secondary outcomes (2)
Initial perfused vessel density
Perfused vessel density measured by Cytocam before spontaneous breathing trial
Measured: 0 hour
Change of perfused vessel density
The difference between the perfused vessel density measure by Cytocam before and after spontaneous breathing trial
Measured: baseline and 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start5 Dec 2019
- Primary completion13 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711590
- Sponsor's protocol ID
- 201909036RINB
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study will be available from the corresponding author upon reasonable request and approval of the research ethic committee.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Change of Microcirculation After Spontaneous Breathing Trial and Ventilator Weaning
- ClinicalTrials.gov ID
- NCT04711590
- Acronym / sponsor ID
- 201909036RINB
- Conditions
- Critically Ill
- Keywords
- ventilator, weaning, microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Jan 2021 (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.
Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Hemodynamic stability and physical reserve are important indicators as well. Microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. We hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. Thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). The microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful extubation | – | Other: Microcirculation examinationThe patients pass the spontaneous breathing trial and are successful extubated without reintubation within 72 hours. . |
| Failed extubation | – | Other: Microcirculation examinationThe patients pass the spontaneous breathing trial and are successful extubated with reintubation within 72 hours. . |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients who are ready for weaning ventilator support and receive spontaneous breathing trial.
Key inclusion criteria (3 listed)
- critically ill patients received ventilator longer than 12 hours
- ready for spontaneous breathing trial
- GCS coma score equal or higher than 8
Key exclusion criteria (3 listed)
- aged less than 20 years
- patient with tracheostomy
- patient and patients' relatives are non-native speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcirculation examinationSublingual microcirculation images were recorded using an incident dark-field video microscope | Other | Failed extubation, Successful extubation |
Primary outcome
Initial total vessel density
Time frame: 0 hour
Total vessel density measured by Cytocam before and after spontaneous breathing trial
Change of total vessel density
Time frame: baseline and 1 hour
The difference between the total vessel density measure by Cytocam before and after spontaneous breathing trial
2 secondary outcomes
Initial perfused vessel density
Time frame: 0 hour
Change of perfused vessel density
Time frame: baseline and 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study will be available from the corresponding author upon reasonable request and approval of the research ethic committee.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Critically Ill, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Dec 2022. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial total vessel density (time frame: 0 hour). The study lists 2 primary outcomes in all. 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 14 Dec 2022; AzTrials last refreshed its copy on 27 Oct 2026.