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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGadjah Mada University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

55 Participants
are grouped into 1 trial group
Group A: ICU Patients on Mechanical Ventilation >48 Hours

Trial outcomes

Primary outcomes

1

Extubation Success Rate

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

Time frame
After extubation

Secondary outcomes

1

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

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated for diaphragmatic excursion and diaphragmatic thickening fraction (ΔTdi%) to predict successful weaning from mechanical ventilation. Receiver Operating Characteristic (ROC) curve analysis will be used to evaluate and compare the clinical utility of RSBI, diaphragmatic excursion, and DTF in predicting extubation success.

Time frame
Prior to extubation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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