Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521515
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Lung Ultrasound Morphology Patterns Predict Weaning Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Lung Ultrasound Morphology Patterns on Treatment Response and Weaning Outcomes in High-Risk Mechanically Ventilated Patients
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This prospective observational study aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients The study will be conducted in the intensive care unit ICU and will include patients who have been on mechanical ventilation for over 24 hours are at high risk for reintubation due to age 65 years or underlying conditions chronic heart or lung disease and have a Lung Ultrasound Score LUS 13
Patients will be stratified into two groups based on their lung ultrasound patterns localized tissue-like patterns TLP and diffuse B-lines DBP Daily lung ultrasound examinations will be performed and patients will receive targeted clinical interventions based on their ultrasound findings such as lung recruitment maneuvers positive end-expiratory pressure PEEP ventilation prone positioning pleural effusion drainage antibiotics for pneumonia and strategies for achieving negative fluid balance
The primary outcome will be the change in Lung Recruitment Score LRS between the TLP and DBP groups which assesses lung recruitment efficiency Secondary outcomes will include the rate of weaning failure duration of mechanical ventilation ICU mortality total ICU stay duration and PaO2FiO2 ratio before and after the spontaneous breathing trial SBT
This study aims to provide insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients potentially leading to improved patient care and outcomes in the ICU setting
Patients will be stratified into two groups based on their lung ultrasound patterns localized tissue-like patterns TLP and diffuse B-lines DBP Daily lung ultrasound examinations will be performed and patients will receive targeted clinical interventions based on their ultrasound findings such as lung recruitment maneuvers positive end-expiratory pressure PEEP ventilation prone positioning pleural effusion drainage antibiotics for pneumonia and strategies for achieving negative fluid balance
The primary outcome will be the change in Lung Recruitment Score LRS between the TLP and DBP groups which assesses lung recruitment efficiency Secondary outcomes will include the rate of weaning failure duration of mechanical ventilation ICU mortality total ICU stay duration and PaO2FiO2 ratio before and after the spontaneous breathing trial SBT
This study aims to provide insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients potentially leading to improved patient care and outcomes in the ICU setting
Detailed Description:
This prospective observational study titled Lung Ultrasound Morphology Patterns Predict Weaning Outcomes LUMP-WO aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients The study will be conducted in the intensive care unit ICU of a tertiary care hospital
Inclusion criteria for the study are 1 mechanical ventilation for over 24 hours before the first spontaneous breathing trial 2 high risk for reintubation due to age 65 years or underlying conditions chronic heart disease or chronic lung disease and 3 complete ultrasound data and initial LUS score 13 Exclusion criteria include 1 age under 18 years pregnancy mechanical ventilation duration less than 24 hours or diaphragmatic dysfunction 2 low risk of extubation failure 3 peripheral neuromuscular disorders or 4 do-not-reintubate order at the first spontaneous breathing trial
Patients will undergo daily lung ultrasound examinations performed by blinded investigators Each lung will be scanned in six regions and ultrasound findings will be categorized into four aeration patterns normal N-score 0 moderate B1-lines score 1 severe B2-lines score 2 and consolidation C-score 3 The global LUS score will range from 0 to 36 Patients will be grouped into TLP if they exhibit a tissue-like pattern in any region or DBP if they display diffuse B-lines and shred signs in most regions
Patients will receive standard medical care and targeted interventions based on their lung ultrasound findings Lung recruitment maneuvers PEEP ventilation prone positioning pleural effusion drainage antibiotics for pneumonia and strategies for achieving negative fluid balance will be utilized as appropriate Weaning criteria will be assessed daily and the Spontaneous Breathing Test SBT will be conducted using a T-tube or mechanical ventilation with low PEEP and pressure support
The primary outcome will be the change in Lung Recruitment Score LRS between the TLP and DBP groups Secondary outcomes will include the rate of weaning failure duration of mechanical ventilation ICU mortality total ICU stay duration and PaO2FiO2 ratio before and after the SBT
Data will be analyzed using appropriate statistical tests and univariate and multivariate regression analyses will be utilized to identify risk factors associated with weaning outcomes
This study aims to provide valuable insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients The findings may contribute to the development of personalized management strategies and improved patient outcomes in the ICU setting The studys results may also help in the early identification of patients at risk of weaning failure allowing for timely interventions and resource allocation
Inclusion criteria for the study are 1 mechanical ventilation for over 24 hours before the first spontaneous breathing trial 2 high risk for reintubation due to age 65 years or underlying conditions chronic heart disease or chronic lung disease and 3 complete ultrasound data and initial LUS score 13 Exclusion criteria include 1 age under 18 years pregnancy mechanical ventilation duration less than 24 hours or diaphragmatic dysfunction 2 low risk of extubation failure 3 peripheral neuromuscular disorders or 4 do-not-reintubate order at the first spontaneous breathing trial
Patients will undergo daily lung ultrasound examinations performed by blinded investigators Each lung will be scanned in six regions and ultrasound findings will be categorized into four aeration patterns normal N-score 0 moderate B1-lines score 1 severe B2-lines score 2 and consolidation C-score 3 The global LUS score will range from 0 to 36 Patients will be grouped into TLP if they exhibit a tissue-like pattern in any region or DBP if they display diffuse B-lines and shred signs in most regions
Patients will receive standard medical care and targeted interventions based on their lung ultrasound findings Lung recruitment maneuvers PEEP ventilation prone positioning pleural effusion drainage antibiotics for pneumonia and strategies for achieving negative fluid balance will be utilized as appropriate Weaning criteria will be assessed daily and the Spontaneous Breathing Test SBT will be conducted using a T-tube or mechanical ventilation with low PEEP and pressure support
The primary outcome will be the change in Lung Recruitment Score LRS between the TLP and DBP groups Secondary outcomes will include the rate of weaning failure duration of mechanical ventilation ICU mortality total ICU stay duration and PaO2FiO2 ratio before and after the SBT
Data will be analyzed using appropriate statistical tests and univariate and multivariate regression analyses will be utilized to identify risk factors associated with weaning outcomes
This study aims to provide valuable insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients The findings may contribute to the development of personalized management strategies and improved patient outcomes in the ICU setting The studys results may also help in the early identification of patients at risk of weaning failure allowing for timely interventions and resource allocation
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