Ultrasound Evaluation of Respiratory Muscles During Mechanical Ventilation Weaning in ICU Patients

NCT07405567 | Not Yet Recruiting

• 1 other identifier: 2024-TBEK 2026/01-03
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Failure of weaning is associated with longer ventilation duration, prolonged ICU stay, and increased risk of complications and death. Therefore, simple and reliable bedside tools are needed to better understand respiratory muscle function and to help predict weaning outcomes. This prospective, observational, single-center study aims to evaluate respiratory muscle function using bedside ultrasound in adult ICU patients with pneumonia receiving invasive mechanical ventilation. The diaphragm, parasternal intercostal muscles, and anterior scalene muscles will be assessed using ultrasound during the weaning process. Measurements will be performed serially, starting from the first day when patients demonstrate meaningful spontaneous breathing effort and continuing until successful extubation, tracheostomy, or ICU mortality. Ultrasound measurements of muscle thickness and thickening fraction will be analyzed in relation to weaning outcomes. In addition, ventilator parameters and commonly used weaning indices will be recorded at the time of each ultrasound assessment. The findings of this study are expected to improve understanding of respiratory muscle involvement during weaning and may contribute to earlier identification of patients at risk of weaning failure.

Conditions

Pneumonia; Invasive Mechanical Ventilation; Weaning From Mechanical Ventilation in Care Unit; Respiratory Muscle Dysfunction

Keywords

Mechanical Ventilation Weaning; Respiratory Muscle Ultrasound; Diaphragm Ultrasound; Parasternal Intercostal Muscle; Anterior Scalene Muscle

Outcome Measures

Primary Outcomes (1)

• Weaning Failure

  Weaning failure is defined as the need for reintubation within 72 hours after planned extubation, requirement for tracheostomy, or death occurring in the intensive care unit before successful liberation from invasive mechanical ventilation.

  From Measurement Day 0 until ICU discharge, up to 72 hours after extubation

Secondary Outcomes (5)

• Diaphragm Thickening Fraction (TFdi)

  From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.

• Parasternal Intercostal Muscle Thickening Fraction (TFic)

  From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.

• Anterior Scalene Muscle Thickening Fraction (STF)

  From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.

• Respiratory Drive and Weaning Indices

  From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.

• Ventilator Parameters During Weaning

  From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.

Study Arms (1)

Pneumonia ICU Patients on Invasive Mechanical Ventilation

This cohort includes adult intensive care unit patients admitted with pneumonia who are receiving invasive mechanical ventilation via endotracheal intubation. All participants will undergo serial bedside ultrasonographic assessments of the diaphragm, parasternal intercostal muscles, and anterior scalene muscles during the weaning process. No therapeutic intervention is assigned as part of the study, and all clinical management decisions, including ventilator settings and weaning strategies, are determined by the treating ICU team according to standard care.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study with no assigned therapeutic intervention. Serial ultrasonographic assessments of respiratory muscles are performed for observational and data collection purposes only, and all clinical care and weaning decisions are made by the treating intensive care unit team according to standard practice.

Pneumonia ICU Patients on Invasive Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older who are admitted to the intensive care unit with pneumonia and require invasive mechanical ventilation via endotracheal intubation. Patients are followed prospectively during the weaning process from mechanical ventilation and undergo serial bedside ultrasonographic assessment of respiratory muscles as part of observational data collection. All patients receive standard intensive care management as determined by the treating clinical team.

You may qualify if:

• Age ≥ 18 years
• Admission to the intensive care unit with a diagnosis of pneumonia
• Receiving invasive mechanical ventilation via endotracheal intubation
• Expected to undergo a weaning process from mechanical ventilation
• Written informed consent obtained from the patient or legally authorized representative

You may not qualify if:

• Known neuromuscular disease affecting respiratory muscles
• High cervical spinal cord injury
• History of major neck, thoracic, or diaphragmatic surgery
• Acute thoracic trauma or pneumothorax
• Central nervous system pathology affecting respiratory drive
• Continuous neuromuscular blocking agent use
• Pregnancy

Sponsors & Collaborators

• Bursa Sevket Yilmaz Training and Research Hospital: lead

Study Sites (1)

Principal Investigator

Bursa, Turkey (Türkiye)

Location

Related Publications (3)

• Bhattacharya D, Esquinas AM, Mandal M. Parasternal Intercostal Muscle Thickness Fraction (PICTF%): Ultrasound a New Tool for Weaning Prediction? Indian J Crit Care Med. 2024 Apr;28(4):404. doi: 10.5005/jp-journals-10071-24665.

  PMID: 38585317 RESULT

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

  PMID: 24949192 RESULT

• Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

  PMID: 17470624 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Gürcan Güler

CONTACT

+90 541 975 0407; gurcanguler.45@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 12, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)