Weaning FailureNCT02915458
Predictive Analysis Software for Successful Weaning From Ventilator of Patients
An observational study of Weaning Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue. The most common index to predict successful weaning is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure
- How many people
- 188 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2018
- 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: 1. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for >24 hours; 2. Patients are ready be weaned to performed a spontaneous breathing trial by 120-min T-piece.
Who may be able to join
- 1. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for >24 hours; 2. Patients are concomitant with presence of the following criteria of ready be weaned, a spontaneous breathing trial (SBT) will then be evaluated by 120-min T-piece:
- clear improvement of the condition that led to mechanical ventilation;
- no acute pulmonary or neuromuscular disease or signs of increased intracranial pressure;
- conscious and lying on a bed with the upper body elevated to a 30◦ angle
- adequate oxygenation (PaO2 ≥ 60mmHg and fraction of inspired oxygen inspired oxygen fraction (FiO2) ≤ 40% with positive end expiratory pressure (PEEP) ≤ 8cm H2O, or PaO2 /FiO2 >150 mmHg);
- no significant respiratory acidosis, PaCO2<50mmHg, or increasing <10% for patients with chronic CO2 retention.
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- stable cardiovascular status (Heat beat ≤140/min, systolic blood pressure 90-160mmHg);
- no requirement for vasopressive or inotropic dugs≥ 8 hours;
- no intravenous sedatives during the previous 24 hours;
- ability to cough while suction;
- afebrile with ≤ 38◦ C temperature.
- negative cuff leakage test: >110ml or >12%
Who cannot join
- Presence of tracheostomy
- Home ventilation prior to ICU admission
- Decision not to re-intubate or withdrawal of care anticipated
- Further surgery requiring sedation planned next 48 hours
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, 33305
Ting-Yu Lin, MD, 886-3-3281200 ext. 5108, yuebaoyuebao@yahoo.com.tw
Ting-Yu Lin, MD
About this study
Official title: Predictive Analysis Software for Successful Weaning From Ventilator of Patients in Critical Condition
Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue. The most common index to predict successful weaning is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned.
The investigators proposed a new mathematical model and algorithm, called WIN, which capture the essential feature of the variability ruling the physiological dynamics to provides better perdition to wean than RSBI.
Read the detailed description
Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue.
It is thus important to decide accurately when patients can be weaned from the ventilator. To increase the weaning success, the present common practice is to conduct spontaneous breathing trials to get physiological signals that may provide the information about capacity of successful weaning. The most common index is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned. Weaning failure usually results from a complex interplay of multiple factors. Thus, predictors targeting a single pathophysiologic mechanism tend to be unreliable for heterogeneous abnormalities.
The investigators proposed a new mathematical model and algorithm, which capture the essential feature of the variability ruling the physiological dynamics. Through the modern adaptive signal processing techniques, the investigators develop an index called WIN, which is evaluated from the 5 minutes continuous physiological signal and provides better perdition to wean than RSBI in a retrospective analysis. In this study, the investigators evaluate the predictive power of WIN and RSBI prospectively in patients undergoing weaning prospectively.
- Conditions
- Weaning Failure
- Keywords
- Weaning, Mechanical ventilation, synchrosqueezing transform
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weaning from mechanical ventilation
The patients could breath by themselves after extubation without any ventilator assistance for 72 hours
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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 Weaning FailureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Lun Lo, Chang Gung Memorial Hospital
- Investigators
- Yu-Lun Lo, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915458
- Sponsor's protocol ID
- 104-6531B
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wu HT, Talmon R, Lo YL. Assess sleep stage by modern signal processing techniques. IEEE Trans Biomed Eng. 2015 Apr;62(4):1159-1168. doi: 10.1109/TBME.2014.2375292. Epub 2014 Nov 26.
PubMed 25438301Wu HT, Hseu SS, Bien MY, Kou YR, Daubechies I. Evaluating physiological dynamics via synchrosqueezing: prediction of ventilator weaning. IEEE Trans Biomed Eng. 2014 Mar;61(3):736-44. doi: 10.1109/TBME.2013.2288497. Epub 2013 Nov 4.
PubMed 24235294
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Analysis Software for Successful Weaning From Ventilator of Patients in Critical Condition
- ClinicalTrials.gov ID
- NCT02915458
- Acronym / sponsor ID
- 104-6531B
- Conditions
- Weaning Failure
- Keywords
- Weaning, Mechanical ventilation, synchrosqueezing transform
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Sep 2016 (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.
Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue. The most common index to predict successful weaning is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned.
The investigators proposed a new mathematical model and algorithm, called WIN, which capture the essential feature of the variability ruling the physiological dynamics to provides better perdition to wean than RSBI.
Detailed description
Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue.
It is thus important to decide accurately when patients can be weaned from the ventilator. To increase the weaning success, the present common practice is to conduct spontaneous breathing trials to get physiological signals that may provide the information about capacity of successful weaning. The most common index is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned. Weaning failure usually results from a complex interplay of multiple factors. Thus, predictors targeting a single pathophysiologic mechanism tend to be unreliable for heterogeneous abnormalities.
The investigators proposed a new mathematical model and algorithm, which capture the essential feature of the variability ruling the physiological dynamics. Through the modern adaptive signal processing techniques, the investigators develop an index called WIN, which is evaluated from the 5 minutes continuous physiological signal and provides better perdition to wean than RSBI in a retrospective analysis. In this study, the investigators evaluate the predictive power of WIN and RSBI prospectively in patients undergoing weaning prospectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for >24 hours; 2. Patients are ready be weaned to performed a spontaneous breathing trial by 120-min T-piece.
Key inclusion criteria (12 listed)
- 1. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for >24 hours; 2. Patients are concomitant with presence of the following criteria of ready be weaned, a spontaneous breathing trial (SBT) will then be evaluated by 120-min T-piece:
- clear improvement of the condition that led to mechanical ventilation;
- no acute pulmonary or neuromuscular disease or signs of increased intracranial pressure;
- conscious and lying on a bed with the upper body elevated to a 30◦ angle
- adequate oxygenation (PaO2 ≥ 60mmHg and fraction of inspired oxygen inspired oxygen fraction (FiO2) ≤ 40% with positive end expiratory pressure (PEEP) ≤ 8cm H2O, or PaO2 /FiO2 >150 mmHg);
Key exclusion criteria (4 listed)
- Presence of tracheostomy
- Home ventilation prior to ICU admission
- Decision not to re-intubate or withdrawal of care anticipated
- Further surgery requiring sedation planned next 48 hours
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
Successful weaning from mechanical ventilation
Time frame: up to 72 hours
The patients could breath by themselves after extubation without any ventilator assistance for 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 25438301Wu HT, Talmon R, Lo YL. Assess sleep stage by modern signal processing techniques. IEEE Trans Biomed Eng. 2015 Apr;62(4):1159-1168. doi: 10.1109/TBME.2014.2375292. Epub 2014 Nov 26.
- Background: PubMed 24235294Wu HT, Hseu SS, Bien MY, Kou YR, Daubechies I. Evaluating physiological dynamics via synchrosqueezing: prediction of ventilator weaning. IEEE Trans Biomed Eng. 2014 Mar;61(3):736-44. doi: 10.1109/TBME.2013.2288497. Epub 2013 Nov 4.
- 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.
Yu-Lun Lo, MD principal investigator
Chang Gung Memorial Hospital
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 Weaning Failure, run by Chang Gung Memorial 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 12 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 24 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Yu Lin, MD (886-3-3281200 ext. 8468, yuebaoyuebao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful weaning from mechanical ventilation (time frame: up to 72 hours). 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 NCT02915458, 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 24 Jul 2018.