Ventilated PatientsECO-WEANINGNCT06609798
Ultrasound Assessment During Weaning from Mechanical Ventilation
An observational study of Ventilated Patients and Weaning Invasive Mechanical Ventilation, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The ECO-WEANING study aims to improve the process of safely removing patients from mechanical ventilation in the Intensive Care Unit (ICU). Some patients have difficulty breathing on their own after being on a ventilator, which can lead to longer hospital stays and complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patients, Weaning Invasive Mechanical Ventilation, ICU
- How many people
- 429 participants
- Where
- 1 siteArgentina
- Study dates
- 10 Jun 2024to 1 Feb 2025
- How long will I take part?
- 2 Months
- 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 hospitalized in critical care units in Latin American countries (Argentina, Bolivia, Ecuador, Chile) and Europe (Italy and Spain) will be included.
Who may be able to join
- Adult patients (18 years or older).
- Receiving mechanical ventilatory assistance for more than 48 hours.
- The patient is deemed ready to undergo a Spontaneous Breathing Trial, as determined by the attending physician.
- Ultrasound measurements are performed between 20 and 30 minutes after the initiation of the trial.
Who cannot join
- Patients with known or diagnosed neuromuscular disease.
- Limitation of therapeutic effort
- History of severe valvulopathy, severe coronary artery disease, known left ventricular ejection fraction \<35%, or known grade 3 diastolic dysfunction, or who are considered candidates for tracheostomy due to their severity.
- History of home ventilatory support
- Patients who do not have a good acoustic window or have any type of limitation to perform pulmonary, cardiac, or diaphragmatic ultrasound.
- Patients who at the discretion of the treating medical team cannot be placed on a T-tube.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos AIres
Buenos Aires, Buenos Aires F.D., C1181ACH
About this study
Official title: Utility of Pulmonary, Diaphragmatic and Cardiac Ultrasound Assessment During Weaning from Mechanical Ventilation in the Critically Ill Patient: a Prospective Observational
The ECO-WEANING study aims to improve the process of safely removing patients from mechanical ventilation in the Intensive Care Unit (ICU). Some patients have difficulty breathing on their own after being on a ventilator, which can lead to longer hospital stays and complications. This study will use ultrasound to assess lung, heart, and diaphragm function before removing the ventilator. Combining these ultrasound results, we hope to identify better patients at high risk of needing mechanical ventilation again. The goal is to help guide care decisions and improve recovery, reducing the need for re-intubation or other interventions.
Read the detailed description
This study is a multicenter, prospective, observational trial to develop an ultrasound-based predictive model for extubation failure in mechanically ventilated ICU patients. Extubation failure, defined as re-intubation or death within 48 hours post-extubation, remains a significant challenge, occurring in 15-35% of cases. Prolonged mechanical ventilation is associated with increased morbidity, infection risk, and hospital costs. Traditional predictors, such as maximal inspiratory pressure (Pimax), rapid shallow breathing index (RSBI or Tobin index), and other clinical parameters, have shown limited accuracy in identifying patients who are ready for extubation.
Recent advances in bedside ultrasound have allowed for the assessment of key physiological functions, such as pulmonary aeration, diaphragmatic function, and cardiac performance, offering a more comprehensive approach to predicting extubation outcomes. In this study, ultrasound will be used to evaluate the modified Lung Ultrasound Score (LUS) for lung aeration, diaphragm excursion, and thickening fraction (TFdi) for diaphragmatic function, and left ventricular diastolic function (E/e') to assess cardiac performance.
Study Procedures The study will include approximately 15 intensive care units (ICUs) across Argentina, Chile, Peru, Ecuador, Italy, Spain, the United States, and Canada. Ethical approval has been obtained from each participating institution. Adult patients (≥18 years) on invasive mechanical ventilation (MV) for at least 48 hours and ready to initiate a spontaneous breathing trial (SBT) will be eligible. Ultrasound assessments will be performed between 20 and 30 minutes after initiating the trial.
Key ultrasound measures include:
Pulmonary Ultrasound (LUS score): Evaluation of anterior and lateral lung regions to assess loss of lung aeration during the SBT.
Cardiac Ultrasound: Assessment of systolic function using mitral annular plane systolic excursion (MAPSE) and tricuspid annular plane systolic excursion (TAPSE) to evaluate right ventricular (RV) and left ventricular (LV) systolic function. Diastolic function will be measured through the E/e' ratio.
Diaphragm Ultrasound: Evaluation of diaphragmatic function through excursion and thickening fraction.
Data from these ultrasound assessments will be collected prospectively and entered into a centralized database. Each patient may be included in the study for multiple extubations if applicable.
Quality Assurance and Data Management
The study employs rigorous data collection and validation procedures, including:
A quality assurance plan that ensures data accuracy and completeness, including site monitoring and auditing.
Data validation checks to ensure consistency with predefined rules. Source data verification through comparison with external data sources, such as medical records and case report forms.
A data dictionary detailing each variable\&#39;s definition, coding, and range, to ensure uniform data entry across all sites.
Standard operating procedures (SOPs) guide the processes of patient recruitment, data collection, and data management.
A sample size assessment determined that the trial requires a sufficient number of patients to ensure the detection of statistically significant differences in extubation outcomes. Additionally, a plan for managing missing data has been developed to address cases where information is unavailable or inconsistent.
Statistical Analysis The primary goal of this study is to create a predictive model for extubation failure, based on lung, diaphragm, and cardiac ultrasound parameters. The primary outcome is extubation failure, defined as the need for re-intubation or death within 48 hours. Secondary outcomes include the predictive performance of the model in patients not requiring preventive non-invasive ventilation (NIV) and in neurocritical patients.
The statistical analysis plan will incorporate both univariate and multivariate analyses to determine the predictive value of each ultrasound parameter. Cox proportional hazard models will be employed to assess time-to-event data, while logistic regression models will be used for binary outcomes such as extubation failure.
By combining these diverse ultrasound measurements, the study aims to provide a robust, non-invasive tool for predicting extubation success or failure, thereby enabling more personalized, evidence-based management of critically ill patients in the ICU.
- Keywords
- Mechanical ventilation, Ultrasound, intensive care unit, Extubation, diaphragm, Lung Ultrasound
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 |
|---|---|---|
| Adult patients during the period of weaning from mechanical ventilation | Adult patients (age ≥18 years) who have been on invasive mechanical ventilation via an endotracheal tube for at least 48 hours and are eligible to begin a spontaneous breathing trial in T-tube mode will be included. Cardiac, diaphragmatic, and pulmonary ultrasound measurements will be performed between 20 and 30 minutes after the start of the spontaneous breathing trial. The ultrasound sequence includes: 1) modified Lung Ultrasound Score (LUS), 2) left ventricular systolic function assessed by MAPSE, 3) right ventricular systolic function assessed by TAPSE, 4) left ventricular diastolic function via E/e' ratio, 5) diaphragmatic excursion, and 6) diaphragmatic thickening fraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters
The primary objective of this study is to develop a predictive model for extubation failure by utilizing lung ultrasound, echocardiography, and diaphragmatic parameters. This model aims to improve the accuracy of identifying patients at risk of re-intubation or other complications after being taken off mechanical ventilation.
Measured: The primary outcome assessment period comprises the first 48 hours after extubation.
Secondary outcomes (4)
To assess the predictive accuracy of the ultrasound model in patients who do not require non-invasive ventilation as a preventive measure against failure
This objective focuses on determining how accurately the ultrasound model can predict extubation failure in patients who are not considered to need non-invasive ventilation (NIV) as a preventive measure. The goal is to assess if the model can reliably identify patients at risk of failure, even when they are not typically considered high-risk based on clinical criteria.
Measured: The evaluation period comprises the first 48 hours after extubation.
Evaluate the predictive performance of the ultrasound model in patients with indication for preventive non-invasive ventilation
In this case, the study aims to determine how well the ultrasound model predicts extubation failure in patients who have been identified as needing non-invasive ventilation to prevent failure. The objective is to validate the model\'s usefulness in this higher-risk group, where preventive measures are already being considered.
Measured: The evaluation period comprises the first 48 hours after extubation.
Examine the correlation between clinical criteria for preventive non-invasive ventilation and the ultrasound model's predictions
This objective aims to explore the relationship between traditional clinical criteria used to prescribe non-invasive ventilation as a preventive measure and the predictions made by the ultrasound-based model. By comparing both approaches, the study will determine how closely they align and whether the model provides added value in decision-making
Measured: The evaluation period comprises the first 48 hours after extubation.
Describe the proportion of extubation failure within 7 days after extubation
This objective seeks to document how many patients experience extubation failure within the first 7 days post-extubation. Understanding this timeframe will provide insights into the critical period for monitoring patients and assessing the accuracy of the ultrasound model in predicting failure during this vulnerable period.
Measured: The evaluation period includes the first 7 days after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start10 Jun 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilated PatientsStudies 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
- 429 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Fernández Ceballos, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609798
- Sponsor's protocol ID
- CEPI N° 12246
- Acronym
- ECO-WEANING
- Status last verified
- Apr 2024
- First submitted
- 19 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguía C, et al. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. 2. Ouanes-Besbes L, Dachraoui F, Ouanes I, Bouneb R, Jalloul F, Dlala M, et al. NT-proBNP levels at spontaneous breathing trial help in the prediction of post-extubation respiratory distress. Intensive Care Med. 2012 May;38(5):788-95. 3. Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, et al. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. 4. Peñuelas O, Frutos-Vivar F, Fernández C, Anzueto A, Epstein SK, Apezteguía C, et al. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. 5. Powers SK, Kavazis AN, Levine S. Prolonged mechanical ventilation alters diaphragmatic structure and function. Crit Care Med. 2009 Oct;37(10 Suppl):S347-53. 6. Trivedi V, Chaudhuri D, Jinah R, Piticaru J, Agarwal A, Liu K, et al. The Usefulness of the Rapid Shallow Breathing Index in Predicting Successful Extubation: A Systematic Review and Meta-analysis. Chest. 2022 Jan;161(1):97-111. 7. Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, et al. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. 8. Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, et al. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. 9. Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. 10. Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Math
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pulmonary, Diaphragmatic and Cardiac Ultrasound Assessment During Weaning from Mechanical Ventilation in the Critically Ill Patient: a Prospective Observational
- ClinicalTrials.gov ID
- NCT06609798
- Acronym / sponsor ID
- ECO-WEANING / CEPI N° 12246
- Keywords
- Mechanical ventilation, Ultrasound, intensive care unit, Extubation, diaphragm, Lung Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 429 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 24 Sep 2024 (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 ECO-WEANING study aims to improve the process of safely removing patients from mechanical ventilation in the Intensive Care Unit (ICU). Some patients have difficulty breathing on their own after being on a ventilator, which can lead to longer hospital stays and complications. This study will use ultrasound to assess lung, heart, and diaphragm function before removing the ventilator. Combining these ultrasound results, we hope to identify better patients at high risk of needing mechanical ventilation again. The goal is to help guide care decisions and improve recovery, reducing the need for re-intubation or other interventions.
Detailed description
This study is a multicenter, prospective, observational trial to develop an ultrasound-based predictive model for extubation failure in mechanically ventilated ICU patients. Extubation failure, defined as re-intubation or death within 48 hours post-extubation, remains a significant challenge, occurring in 15-35% of cases. Prolonged mechanical ventilation is associated with increased morbidity, infection risk, and hospital costs. Traditional predictors, such as maximal inspiratory pressure (Pimax), rapid shallow breathing index (RSBI or Tobin index), and other clinical parameters, have shown limited accuracy in identifying patients who are ready for extubation.
Recent advances in bedside ultrasound have allowed for the assessment of key physiological functions, such as pulmonary aeration, diaphragmatic function, and cardiac performance, offering a more comprehensive approach to predicting extubation outcomes. In this study, ultrasound will be used to evaluate the modified Lung Ultrasound Score (LUS) for lung aeration, diaphragm excursion, and thickening fraction (TFdi) for diaphragmatic function, and left ventricular diastolic function (E/e') to assess cardiac performance.
Study Procedures The study will include approximately 15 intensive care units (ICUs) across Argentina, Chile, Peru, Ecuador, Italy, Spain, the United States, and Canada. Ethical approval has been obtained from each participating institution. Adult patients (≥18 years) on invasive mechanical ventilation (MV) for at least 48 hours and ready to initiate a spontaneous breathing trial (SBT) will be eligible. Ultrasound assessments will be performed between 20 and 30 minutes after initiating the trial.
Key ultrasound measures include:
Pulmonary Ultrasound (LUS score): Evaluation of anterior and lateral lung regions to assess loss of lung aeration during the SBT.
Cardiac Ultrasound: Assessment of systolic function using mitral annular plane systolic excursion (MAPSE) and tricuspid annular plane systolic excursion (TAPSE) to evaluate right ventricular (RV) and left ventricular (LV) systolic function. Diastolic function will be measured through the E/e' ratio.
Diaphragm Ultrasound: Evaluation of diaphragmatic function through excursion and thickening fraction.
Data from these ultrasound assessments will be collected prospectively and entered into a centralized database. Each patient may be included in the study for multiple extubations if applicable.
Quality Assurance and Data Management
The study employs rigorous data collection and validation procedures, including:
A quality assurance plan that ensures data accuracy and completeness, including site monitoring and auditing.
Data validation checks to ensure consistency with predefined rules. Source data verification through comparison with external data sources, such as medical records and case report forms.
A data dictionary detailing each variable\&#39;s definition, coding, and range, to ensure uniform data entry across all sites.
Standard operating procedures (SOPs) guide the processes of patient recruitment, data collection, and data management.
A sample size assessment determined that the trial requires a sufficient number of patients to ensure the detection of statistically significant differences in extubation outcomes. Additionally, a plan for managing missing data has been developed to address cases where information is unavailable or inconsistent.
Statistical Analysis The primary goal of this study is to create a predictive model for extubation failure, based on lung, diaphragm, and cardiac ultrasound parameters. The primary outcome is extubation failure, defined as the need for re-intubation or death within 48 hours. Secondary outcomes include the predictive performance of the model in patients not requiring preventive non-invasive ventilation (NIV) and in neurocritical patients.
The statistical analysis plan will incorporate both univariate and multivariate analyses to determine the predictive value of each ultrasound parameter. Cox proportional hazard models will be employed to assess time-to-event data, while logistic regression models will be used for binary outcomes such as extubation failure.
By combining these diverse ultrasound measurements, the study aims to provide a robust, non-invasive tool for predicting extubation success or failure, thereby enabling more personalized, evidence-based management of critically ill patients in the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients during the period of weaning from mechanical ventilation | – | –Adult patients (age ≥18 years) who have been on invasive mechanical ventilation via an endotracheal tube for at least 48 hours and are eligible to begin a spontaneous breathing trial in T-tube mode will be included. Cardiac, diaphragmatic, and pulmonary ultrasound measurements will be performed between 20 and 30 minutes after the start of the spontaneous breathing trial. The ultrasound sequence includes: 1) modified Lung Ultrasound Score (LUS), 2) left ventricular systolic function assessed by MAPSE, 3) right ventricular systolic function assessed by TAPSE, 4) left ventricular diastolic function via E/e' ratio, 5) diaphragmatic excursion, and 6) diaphragmatic thickening fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in critical care units in Latin American countries (Argentina, Bolivia, Ecuador, Chile) and Europe (Italy and Spain) will be included.
Key inclusion criteria (4 listed)
- Adult patients (18 years or older).
- Receiving mechanical ventilatory assistance for more than 48 hours.
- The patient is deemed ready to undergo a Spontaneous Breathing Trial, as determined by the attending physician.
- Ultrasound measurements are performed between 20 and 30 minutes after the initiation of the trial.
Key exclusion criteria (6 listed)
- Patients with known or diagnosed neuromuscular disease.
- Limitation of therapeutic effort
- History of severe valvulopathy, severe coronary artery disease, known left ventricular ejection fraction \<35%, or known grade 3 diastolic dysfunction, or who are considered candidates for tracheostomy due to their severity.
- History of home ventilatory support
- Patients who do not have a good acoustic window or have any type of limitation to perform pulmonary, cardiac, or diaphragmatic ultrasound.
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
To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters
Time frame: The primary outcome assessment period comprises the first 48 hours after extubation.
The primary objective of this study is to develop a predictive model for extubation failure by utilizing lung ultrasound, echocardiography, and diaphragmatic parameters. This model aims to improve the accuracy of identifying patients at risk of re-intubation or other complications after being taken off mechanical ventilation.
4 secondary outcomes
To assess the predictive accuracy of the ultrasound model in patients who do not require non-invasive ventilation as a preventive measure against failure
Time frame: The evaluation period comprises the first 48 hours after extubation.
Evaluate the predictive performance of the ultrasound model in patients with indication for preventive non-invasive ventilation
Time frame: The evaluation period comprises the first 48 hours after extubation.
Examine the correlation between clinical criteria for preventive non-invasive ventilation and the ultrasound model's predictions
Time frame: The evaluation period comprises the first 48 hours after extubation.
Describe the proportion of extubation failure within 7 days after extubation
Time frame: The evaluation period includes the first 7 days after extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background1. Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguía C, et al. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. 2. Ouanes-Besbes L, Dachraoui F, Ouanes I, Bouneb R, Jalloul F, Dlala M, et al. NT-proBNP levels at spontaneous breathing trial help in the prediction of post-extubation respiratory distress. Intensive Care Med. 2012 May;38(5):788-95. 3. Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, et al. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. 4. Peñuelas O, Frutos-Vivar F, Fernández C, Anzueto A, Epstein SK, Apezteguía C, et al. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. 5. Powers SK, Kavazis AN, Levine S. Prolonged mechanical ventilation alters diaphragmatic structure and function. Crit Care Med. 2009 Oct;37(10 Suppl):S347-53. 6. Trivedi V, Chaudhuri D, Jinah R, Piticaru J, Agarwal A, Liu K, et al. The Usefulness of the Rapid Shallow Breathing Index in Predicting Successful Extubation: A Systematic Review and Meta-analysis. Chest. 2022 Jan;161(1):97-111. 7. Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, et al. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. 8. Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, et al. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. 9. Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. 10. Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Math
- Individual participant dataSharing planned: No
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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 Ventilated Patients and Weaning Invasive Mechanical Ventilation, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 6 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 Sep 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 Argentina. 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?
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?
To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters (time frame: The primary outcome assessment period comprises the first 48 hours after extubation.). 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 NCT06609798, which also lists 1 linked publication.
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 Sep 2024.