Clinical trial NCT06609798: Ultrasound Assessment During Weaning from Mechanical Ventilation
Official title: Utility of Pulmonary, Diaphragmatic and Cardiac Ultrasound Assessment During Weaning from Mechanical Ventilation in the Critically Ill Patient: a Prospective Observational
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventilated Patients
Weaning Invasive Mechanical Ventilation
ICU
Ultrasound
Keywords: Mechanical ventilation
Ultrasound
intensive care unit
Extubation
diaphragm
Lung Ultrasound
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in critical care units in Latin American countries (Argentina, Bolivia, Ecuador, Chile) and Europe (Italy and Spain) will be included.

Brief 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. 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\&amp;#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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with known or diagnosed neuromuscular disease.
* Limitation of therapeutic effort
* History of severe valvulopathy, severe coronary artery disease, known left ventricular ejection fraction \&lt;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.

Primary outcomes:
measure: To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters
timeFrame: The primary outcome assessment period comprises the first 48 hours after extubation.
Secondary outcomes:
measure: To assess the predictive accuracy of the ultrasound model in patients who do not require non-invasive ventilation as a preventive measure against failure
timeFrame: The evaluation period comprises the first 48 hours after extubation.
measure: Evaluate the predictive performance of the ultrasound model in patients with indication for preventive non-invasive ventilation
timeFrame: The evaluation period comprises the first 48 hours after extubation.
measure: Examine the correlation between clinical criteria for preventive non-invasive ventilation and the ultrasound model&#39;s predictions
timeFrame: The evaluation period comprises the first 48 hours after extubation.
measure: Describe the proportion of extubation failure within 7 days after extubation
timeFrame: The evaluation period includes the first 7 days after extubation.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos AIres
state: Capital Federal
Study officials:
References:
citation: 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