Ventilator WeaningNCT07120438
Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventilated ICU Patients
An observational study of Ventilator Weaning and Mechanical Ventilation, run by Gadjah Mada University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Mechanical Ventilation, Respiratory Insufficiency Requiring Mechanical Ventilation
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Mar 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Diaphragmatic Ultrasound and Rapid Shallow Breathing Index (RSBI) in Predicting Weaning Success in Patients on Mechanical Ventilation for More Than 48 Hours in the ICU of Dr. Sardjito Hospital, Yogyakarta
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:
Read more
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:
- Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI.
- Evaluating the correlation between DE values and successful weaning.
- Determining the optimal cutoff values of DE and DTF as predictors of weaning failure.
- Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria.
- Identifying DE and DTF thresholds that may help reduce the risk of reintubation.
Read the detailed description
This observational cohort study aims to investigate the diagnostic utility of diaphragm ultrasound (specifically diaphragmatic excursion (DE) and diaphragm thickening fraction (DTF)) as alternative weaning predictors in adult ICU patients undergoing mechanical ventilation for more than 48 hours. Given the limitations of the Rapid Shallow Breathing Index (RSBI) in predicting weaning outcomes, ultrasound-based parameters offer a promising physiological assessment tool by directly evaluating diaphragmatic function.
Diaphragm ultrasound will be performed within a defined period prior to planned weaning, following standardized imaging protocols to obtain DE and DTF measurements. All ultrasound assessments will be conducted by trained clinicians using point-of-care ultrasound devices available in the ICU. These values will be compared with the corresponding RSBI obtained as part of routine care, without interfering with the clinical decision-making process.
The study will analyze predictive accuracy metrics (such as sensitivity, specificity, and area under the receiver operating characteristic curve) to compare RSBI with diaphragm ultrasound indices. Subgroup analyses will assess the relationship between suboptimal diaphragm function and weaning failure, as well as evaluate threshold values of DE and DTF that may serve as reliable predictors for extubation outcomes. The study will also explore how these indices correlate with rates of reintubation and prolonged weaning.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Success Rate
Proportion of patients who remain extubated for at least 48 hours following planned extubation.
Measured: 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.
Measured: Prior to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Restu Synthana, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120438
- Sponsor's protocol ID
- METAKIC
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Diaphragmatic Ultrasound and Rapid Shallow Breathing Index (RSBI) in Predicting Weaning Success in Patients on Mechanical Ventilation for More Than 48 Hours in the ICU of Dr. Sardjito Hospital, Yogyakarta
- ClinicalTrials.gov ID
- NCT07120438
- Acronym / sponsor ID
- METAKIC
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI.
- Evaluating the correlation between DE values and successful weaning.
- Determining the optimal cutoff values of DE and DTF as predictors of weaning failure.
- Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria.
- Identifying DE and DTF thresholds that may help reduce the risk of reintubation.
Detailed description
This observational cohort study aims to investigate the diagnostic utility of diaphragm ultrasound (specifically diaphragmatic excursion (DE) and diaphragm thickening fraction (DTF)) as alternative weaning predictors in adult ICU patients undergoing mechanical ventilation for more than 48 hours. Given the limitations of the Rapid Shallow Breathing Index (RSBI) in predicting weaning outcomes, ultrasound-based parameters offer a promising physiological assessment tool by directly evaluating diaphragmatic function.
Diaphragm ultrasound will be performed within a defined period prior to planned weaning, following standardized imaging protocols to obtain DE and DTF measurements. All ultrasound assessments will be conducted by trained clinicians using point-of-care ultrasound devices available in the ICU. These values will be compared with the corresponding RSBI obtained as part of routine care, without interfering with the clinical decision-making process.
The study will analyze predictive accuracy metrics (such as sensitivity, specificity, and area under the receiver operating characteristic curve) to compare RSBI with diaphragm ultrasound indices. Subgroup analyses will assess the relationship between suboptimal diaphragm function and weaning failure, as well as evaluate threshold values of DE and DTF that may serve as reliable predictors for extubation outcomes. The study will also explore how these indices correlate with rates of reintubation and prolonged weaning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extubation Success Rate
Time frame: After extubation
Proportion of patients who remain extubated for at least 48 hours following planned extubation.
1 secondary outcome
Diagnostic Accuracy of RSBI, Diaphragmatic Excursion, and Diaphragmatic Thickening Fraction (DTF) for Predicting Extubation Success
Time frame: Prior to extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Weaning and Mechanical Ventilation, run by Gadjah Mada University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meta Restu Synthana, Dr. (6281215621213, meta.restu.synthana@ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation Success Rate (time frame: After extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.