Ventilator WeaningNCT02022839
Role of Lung Ultrasound in Predicting Weaning Outcomes
An observational study of Ventilator Weaning and Ultrasonography, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial summary
We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill patients candidates to liberation from mechanical ventilation in predicting weaning outcomes. The analysis will be taken in two times: immediately before and at the and spontaneous breathing trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Ultrasonography
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2010to Mar 2013
- How long will I take part?
- 2 Days
- 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: Mechanical ventilation patients 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
- Tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: B-lines at Lung Ultrasound Predicts Weaning Failure From Mechanical Ventilation
We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill patients candidates to liberation from mechanical ventilation in predicting weaning outcomes. The analysis will be taken in two times: immediately before and at the and spontaneous breathing trial.
- Conditions
- Ventilator Weaning, Ultrasonography
- Keywords
- mechanical ventilation, weaning, ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning Failure
Measured: Participants will be followed up til weaning success or weaning failure at the end of spontaneous breathing trial. In case of weaning success, then they will be followed for more 48 hours to detect extubation failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- 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
- 250 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Augusto Savi, Hospital Moinhos de Vento
- Investigators
- Ana Carolina P Antonio, MD, Principal investigator, Hospital Moinhos de Vento, Universidade Federal do Rio Grande do SulCassiano Teixeira, MD, PhD, Study chair, Hospital Moinhos de VentoMarli Knorst, MD, PhD, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022839
- Sponsor's protocol ID
- 2010/125
- Status last verified
- Dec 2013
- First submitted
- 27 Apr 2011
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Antonio ACP, Teixeira C, Castro PS, Zanardo AP, Gazzana MB, Knorst M. Usefulness of radiological signs of pulmonary congestion in predicting failed spontaneous breathing trials. J Bras Pneumol. 2017 Jul-Aug;43(4):253-258. doi: 10.1590/S1806-37562016000000360.
PubMed 29364998Antonio AC, Teixeira C, Castro PS, Savi A, Oliveira RP, Gazzana MB, Knorst M. 48-Hour Fluid Balance Does Not Predict a Successful Spontaneous Breathing Trial. Respir Care. 2015 Aug;60(8):1091-6. doi: 10.4187/respcare.03172. Epub 2015 Apr 28.
PubMed 25922544
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-lines at Lung Ultrasound Predicts Weaning Failure From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02022839
- Acronym / sponsor ID
- 2010/125
- Conditions
- Ventilator Weaning, Ultrasonography
- Keywords
- mechanical ventilation, weaning, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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.
We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill patients candidates to liberation from mechanical ventilation in predicting weaning outcomes. The analysis will be taken in two times: immediately before and at the and spontaneous breathing trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanical ventilation patients 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 (1 listed)
- Tracheostomy
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
Weaning Failure
Time frame: Participants will be followed up til weaning success or weaning failure at the end of spontaneous breathing trial. In case of weaning success, then they will be followed for more 48 hours to detect extubation failure.
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 30 Dec 2013.
- Derived from this study: PubMed 29364998Antonio ACP, Teixeira C, Castro PS, Zanardo AP, Gazzana MB, Knorst M. Usefulness of radiological signs of pulmonary congestion in predicting failed spontaneous breathing trials. J Bras Pneumol. 2017 Jul-Aug;43(4):253-258. doi: 10.1590/S1806-37562016000000360.
- Derived from this study: PubMed 25922544Antonio AC, Teixeira C, Castro PS, Savi A, Oliveira RP, Gazzana MB, Knorst M. 48-Hour Fluid Balance Does Not Predict a Successful Spontaneous Breathing Trial. Respir Care. 2015 Aug;60(8):1091-6. doi: 10.4187/respcare.03172. Epub 2015 Apr 28.
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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.
Ana Carolina P Antonio, MD principal investigator
Hospital Moinhos de Vento, Universidade Federal do Rio Grande do Sul
Cassiano Teixeira, MD, PhD study chair
Hospital Moinhos de Vento
Marli Knorst, MD, PhD study chair
Federal University of Rio Grande do Sul
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 Ventilator Weaning and Ultrasonography, run by Hospital Moinhos de Vento at 1 site in Brazil.
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 1 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 30 Dec 2013. 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 Brazil. 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?
Weaning Failure (time frame: Participants will be followed up til weaning success or weaning failure at the end of spontaneous breathing trial. In case of weaning success, then they will be followed for more 48 hours to detect extubation failure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022839, which also lists 2 linked publications.
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 30 Dec 2013.