Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609798
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Ultrasound Assessment During Weaning from Mechanical Ventilation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Utility of Pulmonary Diaphragmatic and Cardiac Ultrasound Assessment During Weaning from Mechanical Ventilation in the Critically Ill Patient a Prospective Observational
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECO-WEANING
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 Ee 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 Ee 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 variableamp39s 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
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 Ee 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 Ee 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 variableamp39s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None