Lung Ultrasound Morphology Patterns Predict Weaning Outcomes

NCT06521515 | Recruiting

• 1 other identifier: LUMP-WO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Retrospective

Keywords

weaning; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• weaning failure rates

  through study completion,up to 28 days

• duration of mechanical ventilation

  through study completion,up to 28 days

• ICU mortality

  through study completion,up to 28 days

• total ICU stay duration

  through study completion,up to 28 days

• PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT)

  through study completion,up to 28 days

Study Arms (2)

TLP group

Patients were grouped into TLP if they exhibited a tissue-like pattern in any region

Diagnostic Test: Lung Ultrasound Morphology Patterns

DBP group

Patients were grouped into DBP if they displayed diffuse B-lines and shred signs in most regions.

Diagnostic Test: Lung Ultrasound Morphology Patterns

Interventions

Lung Ultrasound Morphology Patterns DIAGNOSTIC_TEST

Two blinded investigators conducted daily lung ultrasound examinations. Each lung was scanned in six regions, categorizing ultrasound findings 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 ranged from 0 to 36. Patients were grouped into TLP if they exhibited a tissue-like pattern in any region or DBP if they displayed diffuse B-lines and shred signs in most regions. Localized TLPs indicated concentrated areas of non-aeration.

DBP group; TLP group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Hongyu He

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 29732586 RESULT

• 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.

  PMID: 30372119 RESULT

• 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.

  PMID: 26951426 RESULT

Study Officials

• Ming Zhong, Ph.D

  Fudan University

  STUDY CHAIR

Central Study Contacts

Hongyu He

CONTACT

021-64041990; he.hongyu@zs-hospital.sh.cn

Lizhen Xuan

CONTACT

021-64041990; xuan.lizhen@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the publication of the primary study results, the IPD will be available for request by other researchers for a period of 6 to 36 months.
• Access Criteria: Researchers interested in obtaining the IPD must submit a written application, detailing the research purpose, proposed analysis plan, and data usage and protection plan. All applications will be reviewed by the research team to ensure that the proposed research is consistent with the informed consent provided by the original study participants and complies with relevant ethical and regulatory requirements. Access to the IPD may require the execution of a data use agreement to stipulate the terms of data usage, storage, sharing, etc.

Locations

CN (1)