Clinical trial NCT06521515: Lung Ultrasound Morphology Patterns Predict Weaning Outcomes
Official title: The Impact of Lung Ultrasound Morphology Patterns on Treatment Response and Weaning Outcomes in High-Risk Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retrospective
Keywords: weaning
ultrasound
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be retrospective. Based on lung ultrasound morphology patterns, patients will be stratified into localized tissue-like patterns (TLP) and diffuse B-lines (DBP) groups. The study will enroll a diverse population to ensure generalizability and comprehensively analyze the relationship between lung ultrasound morphology patterns, treatment response, and weaning outcomes.

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 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.

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 PaO2/FiO2 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 study's results may also help in the early identification of patients at risk of weaning failure, allowing for timely interventions and resource allocation.

Eligibility criteria: Inclusion criteria:(1) age ≥18 years, (2) on mechanical ventilation \>24 hours before the first spontaneous breathing trial, (3) high risk for reintubation due to age (\>65 years) or chronic heart or lung disease, and (4) complete ultrasound data and initial LUS \>13.

Exclusion criteria:(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.

Primary outcomes:
measure: LRS
timeFrame: through study completion，up to 28 days
Secondary outcomes:
measure: weaning failure rates
timeFrame: through study completion,up to 28 days
measure: duration of mechanical ventilation
timeFrame: through study completion,up to 28 days
measure: ICU mortality
timeFrame: through study completion,up to 28 days
measure: total ICU stay duration
timeFrame: through study completion,up to 28 days
measure: PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT)
timeFrame: through study completion,up to 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hongyu He
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ming Zhong, Ph.D
role: STUDY_CHAIR
References:
citation: Bello G, Blanco P. Lung Ultrasonography for Assessing Lung Aeration in Acute Respiratory Distress Syndrome: A Narrative Review. J Ultrasound Med. 2019 Jan;38(1):27-37. doi: 10.1002/jum.14671. Epub 2018 May 6.
citation: Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
citation: Mayo P, Volpicelli G, Lerolle N, Schreiber A, Doelken P, Vieillard-Baron A. Ultrasonography evaluation during the weaning process: the heart, the diaphragm, the pleura and the lung. Intensive Care Med. 2016 Jul;42(7):1107-17. doi: 10.1007/s00134-016-4245-3. Epub 2016 Mar 7.