Lung Ultrasound Morphology Patterns Predict Weaning Outcomes
NCT Number: NCT06521515
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Retrospective
Interventions: DIAGNOSTIC_TEST: Lung Ultrasound Morphology Patterns
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-01
Completion Date: 2025-12-30
Locations: Hongyu He, Shanghai, Shanghai, 200032, China

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 PaO2/FiO2 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.

Primary Outcome Measures: LRS, The primary endpoint of the study was the change in Lung Recruitment Score (LRS) between the TLP and DBP groups. LRS assesses lung recruitment efficiency, assigning positive scores for reaeration and negative scores for loss of aeration (, through study completion，up to 28 days
Secondary Outcome Measures: weaning failure rates, defined as inability to successfully complete a spontaneous breathing trial, need for mechanical ventilation reintroduction within 48 hours post-weaning, or mortality related to weaning., through study completion,up to 28 days|duration of mechanical ventilation, the total number of days or hours a patient receives invasive mechanical ventilation support, through study completion,up to 28 days|ICU mortality, the proportion of patients who die during their stay in the intensive care unit (ICU)., through study completion,up to 28 days|total ICU stay duration, the number of days a patient remains in the ICU from admission to discharge, transfer to another unit, or death., through study completion,up to 28 days|PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT), The PaO2/FiO2 ratio will be calculated by dividing the partial pressure of arterial oxygen (PaO2) by the fraction of inspired oxygen (FiO2). Measurements will be taken at two time points: (1) immediately before the start of the SBT and (2) at the end of the SBT or at the time of SBT failure., through study completion,up to 28 days