Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventilated ICU Patients

NCT07120438 | Not Yet Recruiting

• 1 other identifier: METAKIC
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours. The main question it aims to answer is: Which is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion \[DE\] and Diaphragm Thickening Fraction \[DTF\]) or RSBI, in patients ventilated \>48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta? Participants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes. Secondary objectives include:

1. 1.Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI.
2. 2.Evaluating the correlation between DE values and successful weaning.
3. 3.Determining the optimal cutoff values of DE and DTF as predictors of weaning failure.
4. 4.Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria.
5. 5.Identifying DE and DTF thresholds that may help reduce the risk of reintubation.

Conditions

Ventilator Weaning; Mechanical Ventilation; Respiratory Insufficiency Requiring Mechanical Ventilation; Weaning From Mechanical Ventilation; Weaning From Mechanical Ventilation in Care Unit; Intensive Care Unit Patients

Keywords

Diaphragmatic Ultrasound; Rapid Shallow Breathing Index; Diaphragm Thickening Fraction; Diaphragm Excursion; Weaning Prediction; ICU; Weaning Failure

Outcome Measures

Primary Outcomes (1)

• Extubation Success Rate

  Proportion of patients who remain extubated for at least 48 hours following planned extubation.

  After extubation

Secondary Outcomes (1)

• Diagnostic Accuracy of RSBI, Diaphragmatic Excursion, and Diaphragmatic Thickening Fraction (DTF) for Predicting Extubation Success

  Prior to extubation

Study Arms (1)

ICU Patients on Mechanical Ventilation >48 Hours

This cohort includes adult patients admitted to the Intensive Care Unit (ICU) who have been on mechanical ventilation for more than 48 hours. Each participant undergoes assessment using both the Rapid Shallow Breathing Index (RSBI) and diaphragm ultrasonography, including measurements of diaphragmatic excursion (DE) and diaphragmatic thickening fraction (DTF). These assessments are conducted prior to extubation to evaluate their predictive accuracy in determining weaning success or failure.

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 subjects who meet the predetermined criteria. The target population refers to the broader group to which the results of this study are intended to be applied. This population is general in nature but limited by clinical and demographic characteristics. The accessible population is a subset of the target population, defined by place and time, which can be reached by the researcher and will ultimately serve as the source of study participants (Sastroasmoro and Ismail, 2008).The target population in this study comprises adult male and female patients who are on mechanical ventilation in the Intensive Care Unit (ICU) at Dr. Sardjito Hospital, Yogyakarta. The accessible population includes patients with indications for weaning from mechanical ventilation in the ICU of Dr. Sardjito Hospital during the study period.

You may qualify if:

• Patients who have been on mechanical ventilation for more than 48 hours
• Adult patients aged ≥18 years
• Patients who meet the criteria for hemodynamic stability for weaning
• Patients or their families have provided written informed consent
• Patients with FiO₂ \< 50%, PEEP level \< 5 cm H₂O, respiratory rate \< 30 breaths per minute, PaO₂/FiO₂ \> 200, and GCS \> 13
• Patients who have successfully completed the Spontaneous Awakening Trial (SAT) and Spontaneous Breathing Trial (SBT)

You may not qualify if:

• Patients with neuromuscular disorders, anatomical abnormalities of the diaphragm, or diaphragmatic palsy
• Patients with a history of severe thoracic trauma affecting diaphragm function on one or both sides
• Pregnancy

Sponsors & Collaborators

• Gadjah Mada University: lead

Central Study Contacts

Meta Restu Synthana, Dr.

CONTACT

6281215621213; meta.restu.synthana@ugm.ac.id

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Intensive Care

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08