Respiratory InsufficiencyNCT07144878
Parasternal Intercostal Ultrasound vs RSBI for Weaning Prediction
A study testing Parasternal Intercostal Ultrasound and RSBI Assessment in people with Respiratory Insufficiency and Weaning, Ventilator, run by Benha University at 1 site in Egypt.
Trial summary
Mechanical ventilation is essential in the management of critically ill patients, but deciding the proper time to wean and extubate remains a significant challenge. Extubation failure is associated with poor outcomes, including prolonged intensive care unit stay, higher risk of complications, and increased mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency, Weaning, Ventilator, Respiration, Artificial
- What is being tested?
- Parasternal Intercostal Ultrasound and RSBI Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2023to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Both sexes
- Patients invasively mechanically ventilated for up to 24 hours and ready to undergo a spontaneous breathing trial
- Patients considered ready for spontaneous breathing trial if all of the following were met:
- Alert and afebrile
- Fraction of inspired oxygen less than 50 percent
Show all 11Show fewer
- Positive end-expiratory pressure less than or equal to 8 centimeters of water
- Ratio of arterial oxygen partial pressure to fraction of inspired oxygen greater than 200
- Arterial blood pH between 7.35 and 7.45
- Respiratory rate less than or equal to 35 breaths per minute
- Hemodynamically stable without vasopressor support
Who cannot join
- Age younger than 18 years
- Pregnancy
- Surgical dressings near or over the sternum that prevent ultrasound examination
- Body mass index less than 18.5 kilograms per square meter (underweight)
- Body mass index greater than or equal to 40 kilograms per square meter (morbid obesity)
- Primary neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Parasternal Intercostal Muscle Thickness Versus Rapid Shallow Breathing Index for Predicting Weaning From Mechanical Ventilation
Mechanical ventilation is essential in the management of critically ill patients, but deciding the proper time to wean and extubate remains a significant challenge. Extubation failure is associated with poor outcomes, including prolonged intensive care unit stay, higher risk of complications, and increased mortality. The rapid shallow breathing index (RSBI) is widely used to predict weaning readiness, but its predictive accuracy is limited. Recently, ultrasound evaluation of respiratory muscles, particularly the parasternal intercostal muscle, has been proposed as a promising bedside tool to assess respiratory effort and load.
This comparative clinical trial was conducted on adult intensive care unit patients at Benha University Hospital who were mechanically ventilated for ≤24 hours and ready for a spontaneous breathing trial. Each patient underwent both rapid shallow breathing index (RSBI) measurement and parasternal intercostal muscle ultrasound prior to the trial. Patients were classified into successful or failed weaning groups based on trial outcome. The study compared the diagnostic accuracy of both methods and aimed to determine whether ultrasound assessment of the parasternal intercostal muscle offers a more reliable predictor of weaning success than rapid shallow breathing index (RSBI).
- Conditions
- Respiratory Insufficiency, Weaning, Ventilator, Respiration, Artificial, Intensive Care Units, Respiratory Muscles
- Being tested
- Parasternal Intercostal Ultrasound and RSBI Assessment
- Keywords
- Mechanical ventilation, Weaning from ventilation, Extubation outcome, Rapid Shallow Breathing Index (RSBI), Parasternal intercostal muscle ultrasound, Respiratory muscle dysfunction, Spontaneous breathing trial (SBT), Critical care
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal Intercostal Ultrasound and RSBI AssessmentDiagnostic test
Participants underwent ultrasonographic evaluation of the parasternal intercostal muscle using a high-frequency linear probe to measure thickness and the thickening fraction during respiration. In addition, the Rapid Shallow Breathing Index was calculated from ventilator-displayed values under standardized settings: pressure support equal to zero centimeters of water and positive end-expiratory pressure equal to zero centimeters of water. Both assessments were performed immediately prior to a spontaneous breathing trial to evaluate their predictive accuracy for successful weaning from mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Parasternal Intercostal Ultrasound and RSBI Assessment | Other | All enrolled patients underwent ultrasonographic assessment of the parasternal intercostal muscle thickness and calculation of thickening fraction, as well as measurement of the Rapid Shallow Breathing Index (RSBI) using standard ventilator settings. These assessments were performed prior to a 30-minute spontaneous breathing trial. Patients were subsequently classified into successful or failed weaning groups based on trial outcome. Receives: Diagnostic Test: Parasternal Intercostal Ultrasound and RSBI Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of parasternal intercostal muscle thickening fraction measured by ultrasound versus Rapid Shallow Breathing Index for predicting successful weaning from mechanical ventilation
The outcome was assessed by comparing two diagnostic measurements: (1) parasternal intercostal muscle thickening fraction, calculated as the difference between end-inspiratory and end-expiratory muscle thickness divided by end-expiratory thickness, measured using bedside ultrasound; and (2) the Rapid Shallow Breathing Index, calculated as respiratory rate divided by tidal volume, recorded from ventilator-displayed values under standardized zero-support settings. Predictive accuracy for successful weaning was evaluated using receiver operating characteristic analysis, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve. Successful weaning was defined as tolerating a 30-minute spontaneous breathing trial without signs of failure.
Measured: Baseline, immediately prior to the spontaneous breathing trial
Secondary outcomes (2)
Sensitivity and specificity of parasternal intercostal muscle thickening fraction and Rapid Shallow Breathing Index in predicting successful weaning
The sensitivity, specificity, positive predictive value, and negative predictive value of parasternal intercostal muscle thickening fraction measured by ultrasound and Rapid Shallow Breathing Index were calculated to assess their ability to predict successful weaning from mechanical ventilation.
Measured: Baseline, immediately prior to the spontaneous breathing trial
Comparison of area under the receiver operating characteristic curve between parasternal intercostal muscle thickening fraction and Rapid Shallow Breathing Index
Receiver operating characteristic curve analysis was performed to compare the diagnostic performance of parasternal intercostal muscle thickening fraction measured by ultrasound and Rapid Shallow Breathing Index. The area under the curve, accuracy, and statistical significance of the difference between the two methods were reported.
Measured: Baseline, immediately prior to the spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start3 Oct 2023
- Primary completion1 Apr 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled patients underwent both RSBI measurement and parasternal intercostal muscle ultrasound prior to spontaneous breathing trial, and outcomes were analyzed by weaning success or failure.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mahmoud Ahmed Shady, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144878
- Sponsor's protocol ID
- MD 3-11-2023
- Status last verified
- Aug 2025
- First submitted
- 21 Feb 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Parasternal Intercostal Muscle Thickness Versus Rapid Shallow Breathing Index for Predicting Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07144878
- Acronym / sponsor ID
- MD 3-11-2023
- Conditions
- Respiratory Insufficiency, Weaning, Ventilator, Respiration, Artificial, Intensive Care Units, Respiratory Muscles
- Keywords
- Mechanical ventilation, Weaning from ventilation, Extubation outcome, Rapid Shallow Breathing Index (RSBI), Parasternal intercostal muscle ultrasound, Respiratory muscle dysfunction, Spontaneous breathing trial (SBT), Critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 28 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.
Mechanical ventilation is essential in the management of critically ill patients, but deciding the proper time to wean and extubate remains a significant challenge. Extubation failure is associated with poor outcomes, including prolonged intensive care unit stay, higher risk of complications, and increased mortality. The rapid shallow breathing index (RSBI) is widely used to predict weaning readiness, but its predictive accuracy is limited. Recently, ultrasound evaluation of respiratory muscles, particularly the parasternal intercostal muscle, has been proposed as a promising bedside tool to assess respiratory effort and load.
This comparative clinical trial was conducted on adult intensive care unit patients at Benha University Hospital who were mechanically ventilated for ≤24 hours and ready for a spontaneous breathing trial. Each patient underwent both rapid shallow breathing index (RSBI) measurement and parasternal intercostal muscle ultrasound prior to the trial. Patients were classified into successful or failed weaning groups based on trial outcome. The study compared the diagnostic accuracy of both methods and aimed to determine whether ultrasound assessment of the parasternal intercostal muscle offers a more reliable predictor of weaning success than rapid shallow breathing index (RSBI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients underwent both RSBI measurement and parasternal intercostal muscle ultrasound prior to spontaneous breathing trial, and outcomes were analyzed by weaning success or failure.
| Arm | Type | Receives |
|---|---|---|
| Parasternal Intercostal Ultrasound and RSBI Assessment | Other | Diagnostic Test: Parasternal Intercostal Ultrasound and RSBI AssessmentAll enrolled patients underwent ultrasonographic assessment of the parasternal intercostal muscle thickness and calculation of thickening fraction, as well as measurement of the Rapid Shallow Breathing Index (RSBI) using standard ventilator settings. These assessments were performed prior to a 30-minute spontaneous breathing trial. Patients were subsequently classified into successful or failed weaning groups based on trial outcome. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older
- Both sexes
- Patients invasively mechanically ventilated for up to 24 hours and ready to undergo a spontaneous breathing trial
- Patients considered ready for spontaneous breathing trial if all of the following were met:
Key exclusion criteria (6 listed)
- Age younger than 18 years
- Pregnancy
- Surgical dressings near or over the sternum that prevent ultrasound examination
- Body mass index less than 18.5 kilograms per square meter (underweight)
- Body mass index greater than or equal to 40 kilograms per square meter (morbid obesity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasternal Intercostal Ultrasound and RSBI AssessmentParticipants underwent ultrasonographic evaluation of the parasternal intercostal muscle using a high-frequency linear probe to measure thickness and the thickening fraction during respiration. In addition, the Rapid Shallow Breathing Index was calculated from ventilator-displayed values under standardized settings: pressure support equal to zero centimeters of water and positive end-expiratory pressure equal to zero centimeters of water. Both assessments were performed immediately prior to a spontaneous breathing trial to evaluate their predictive accuracy for successful weaning from mechanical ventilation. | Diagnostic test | Parasternal Intercostal Ultrasound and RSBI Assessment |
Primary outcome
Diagnostic accuracy of parasternal intercostal muscle thickening fraction measured by ultrasound versus Rapid Shallow Breathing Index for predicting successful weaning from mechanical ventilation
Time frame: Baseline, immediately prior to the spontaneous breathing trial
The outcome was assessed by comparing two diagnostic measurements: (1) parasternal intercostal muscle thickening fraction, calculated as the difference between end-inspiratory and end-expiratory muscle thickness divided by end-expiratory thickness, measured using bedside ultrasound; and (2) the Rapid Shallow Breathing Index, calculated as respiratory rate divided by tidal volume, recorded from ventilator-displayed values under standardized zero-support settings. Predictive accuracy for successful weaning was evaluated using receiver operating characteristic analysis, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve. Successful weaning was defined as tolerating a 30-minute spontaneous breathing trial without signs of failure.
2 secondary outcomes
Sensitivity and specificity of parasternal intercostal muscle thickening fraction and Rapid Shallow Breathing Index in predicting successful weaning
Time frame: Baseline, immediately prior to the spontaneous breathing trial
Comparison of area under the receiver operating characteristic curve between parasternal intercostal muscle thickening fraction and Rapid Shallow Breathing Index
Time frame: Baseline, immediately prior to the spontaneous breathing trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal Intercostal Ultrasound and RSBI Assessment in people with Respiratory Insufficiency and Weaning, Ventilator, run by Benha University at 1 site in Egypt.
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 11 inclusion and 6 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: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of parasternal intercostal muscle thickening fraction measured by ultrasound versus Rapid Shallow Breathing Index for predicting successful weaning from mechanical ventilation (time frame: Baseline, immediately prior to the spontaneous breathing trial). 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 28 Aug 2025.