Weaning FailureNCT04554095
Development of a Multimodal Index to Improve the Predictive Value of Success in Weaning From Mechanical Ventilation
An observational study of Weaning Failure and Mechanical Ventilation Complication, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Weaning from mechanical ventilation (MV) is a complex process in which patients are liberated from the ventilator. Prolongued weaning and weaning failure, defined as the need for reintubation, have different adverse effects, including prolongation of MV, intensive care unit (ICU) and hospital stay, and are also… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Mechanical Ventilation Complication
- What is being tested?
- Clinical data collection
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 1 Dec 2024
- 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: Patients admitted to the ICU of the Parc Taulí Universitary Hospital undergoing MV and starting the weaning process according to the protocol established for usual clinical care practice.
Who may be able to join
- Patients with MV> 24 hours.
- Patients with orotracheal tube.
- Patients who meet the classic criteria of weaning from the MV defined as:
- Improvement or resolution of the cause required for MV. PaO2> 60mmHg with FiO2≤0.4 and PEEP ≤8cm H2O. Glasgow Coma Score> 10 Temperature <38 ° C. Hemoglobin> 8g / dL No need for vasoactive drugs or at doses <5μg / kg / min Obtaining informed consent.
Who cannot join
- Tracheostomy patients.
- Patients with neurological pathology with involvement of the brainstem.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Candelaria De Haro
Sabadell, Barcelona, 08208
Candelaria De Haro, MD, 0034937231010 ext. 21158, cdeharo@tauli.cat
About this study
Weaning from mechanical ventilation (MV) is a complex process in which patients are liberated from the ventilator. Prolongued weaning and weaning failure, defined as the need for reintubation, have different adverse effects, including prolongation of MV, intensive care unit (ICU) and hospital stay, and are also associated with increased incidence of ventilator-associated pneumonia and high mortality. The rate of weaning failure is high, even when the classic extubation criteria are met, so it is necessary to improve scores that allow predicting and determining the ideal time for MV withdrawal.
The aim of this study is to design a new multimodal index to predict and optimize weaning results in a personalized way, based on the use and interpretation of data derived from continuous monitoring of critically ill patients. The new multimodal index, in addition to classical respiratory parameters, will include parameters related to patient-ventilator interaction (asynchronies), diaphragmatic function, cardiovascular status and autonomic nervous system function (ANS).
The investigators have designed a prospective observational study that will include 126 critical patients from a medical-surgical ICU that meet the classical criteria for weaning. The management of the patients, as well as the weaning process, will be carried out following the usual protocol. In addition to the classical weaning predictor data, data on the patient-ventilator interaction and the function of the autonomic nervous system will be collected by means of specific software (BetterCare). Cardiovascular and diaphragmatic function will be evaluated using ultrasound. Based on the advanced analysis of data from different devices collected throughout the mechanical ventilation period, it will be designed a "personalized" weaning score that should improve the accuracy of the decision-making process and therefore reduce morbidity and mortality. Additional benefits would include lowering health care costs without increasing adverse events.
- Being tested
- Clinical data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
Respiratory parameters, analytic values, lung ultrasound and echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Multimodal index for weaning prediction evaluation
Number of successful weanings evaluated through the new multi-modal index compared to the classic indexes
Measured: 48 hours after mechanical ventilation withdrawal
Secondary outcomes (1)
Predictive value of patient-ventilator interaction
association between asynchronies and weaning failure
Measured: From day 1 of mechanical ventilation until 48 hours after mechanical ventilation withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start4 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candelaria de Haro, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554095
- Sponsor's protocol ID
- Multimodal Weaning
- Status last verified
- Feb 2024
- First submitted
- 31 Aug 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multimodal Index to Improve the Predictive Value of Success in Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04554095
- Acronym / sponsor ID
- Multimodal Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Sep 2020 (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 from mechanical ventilation (MV) is a complex process in which patients are liberated from the ventilator. Prolongued weaning and weaning failure, defined as the need for reintubation, have different adverse effects, including prolongation of MV, intensive care unit (ICU) and hospital stay, and are also associated with increased incidence of ventilator-associated pneumonia and high mortality. The rate of weaning failure is high, even when the classic extubation criteria are met, so it is necessary to improve scores that allow predicting and determining the ideal time for MV withdrawal.
The aim of this study is to design a new multimodal index to predict and optimize weaning results in a personalized way, based on the use and interpretation of data derived from continuous monitoring of critically ill patients. The new multimodal index, in addition to classical respiratory parameters, will include parameters related to patient-ventilator interaction (asynchronies), diaphragmatic function, cardiovascular status and autonomic nervous system function (ANS).
The investigators have designed a prospective observational study that will include 126 critical patients from a medical-surgical ICU that meet the classical criteria for weaning. The management of the patients, as well as the weaning process, will be carried out following the usual protocol. In addition to the classical weaning predictor data, data on the patient-ventilator interaction and the function of the autonomic nervous system will be collected by means of specific software (BetterCare). Cardiovascular and diaphragmatic function will be evaluated using ultrasound. Based on the advanced analysis of data from different devices collected throughout the mechanical ventilation period, it will be designed a "personalized" weaning score that should improve the accuracy of the decision-making process and therefore reduce morbidity and mortality. Additional benefits would include lowering health care costs without increasing adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU of the Parc Taulí Universitary Hospital undergoing MV and starting the weaning process according to the protocol established for usual clinical care practice.
Key inclusion criteria (4 listed)
- Patients with MV> 24 hours.
- Patients with orotracheal tube.
- Patients who meet the classic criteria of weaning from the MV defined as:
- Improvement or resolution of the cause required for MV. PaO2> 60mmHg with FiO2≤0.4 and PEEP ≤8cm H2O. Glasgow Coma Score> 10 Temperature <38 ° C. Hemoglobin> 8g / dL No need for vasoactive drugs or at doses <5μg / kg / min Obtaining informed consent.
Key exclusion criteria (2 listed)
- Tracheostomy patients.
- Patients with neurological pathology with involvement of the brainstem.
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 |
|---|---|---|
| Clinical data collectionRespiratory parameters, analytic values, lung ultrasound and echocardiography | Other | – |
Primary outcome
Multimodal index for weaning prediction evaluation
Time frame: 48 hours after mechanical ventilation withdrawal
Number of successful weanings evaluated through the new multi-modal index compared to the classic indexes
1 secondary outcome
Predictive value of patient-ventilator interaction
Time frame: From day 1 of mechanical ventilation until 48 hours after mechanical ventilation withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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 Weaning Failure and Mechanical Ventilation Complication, run by Corporacion Parc Tauli at 1 site in Spain.
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 4 inclusion and 2 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 7 Feb 2024. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multimodal index for weaning prediction evaluation (time frame: 48 hours after mechanical ventilation withdrawal). 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 7 Feb 2024.