Ventilator WeaningNCT07897617
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
An observational study of Ventilator Weaning and Respiratory Insufficiency, run by Inonu University.
Trial summary
The purpose of this study is to find out whether diaphragm ultrasound measurements, alone or combined with the rapid shallow breathing index (RSBI), can better predict successful removal of the breathing tube in adult intensive care unit patients on mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Respiratory Insufficiency
- What is being tested?
- Diaphragm Ultrasonography and Rapid Shallow Breathing Index
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2028
- 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: Adult patients receiving invasive mechanical ventilation in the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center who are scheduled for a spontaneous breathing trial.
Who may be able to join
- Age 18 years or older
- Invasive mechanical ventilation via an orotracheal or nasotracheal tube for at least 48 hours
- Planned spontaneous breathing trial
- Meeting weaning criteria with a clinical decision for extubation
- Informed consent obtained from a legally authorized representative
Who cannot join
- Diaphragm paralysis
- Neuromuscular disease
- High cervical spinal cord injury
- Pregnancy
- Inadequate ultrasound image quality
- Tracheostomy
Show all 12Show fewer
- Severe obesity (BMI > 35-40 kg/m2)
- Advanced COPD or chronic respiratory failure
- History of phrenic nerve injury (e.g., after cardiac surgery)
- Neuromuscular blocking agent administration within the previous 24 hours
- Inability to cooperate with the SBT due to severe agitation or delirium
- Palliative/terminal care or life expectancy of less than 24 hours
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: The Value of Combining Diaphragm Thickening Fraction and Rapid Shallow Breathing Index in Predicting Extubation Success in Intensive Care Unit Patients: A Prospective Observational Study
The purpose of this study is to find out whether diaphragm ultrasound measurements, alone or combined with the rapid shallow breathing index (RSBI), can better predict successful removal of the breathing tube in adult intensive care unit patients on mechanical ventilation. Diaphragm thickening fraction and diaphragm excursion are measured with bedside ultrasound during the spontaneous breathing trial. Patients are followed after extubation to determine whether they need to be reintubated. The study does not change patient treatment; all measurements are non-invasive.
Read the detailed description
Weaning from mechanical ventilation is a critical phase of intensive care. Premature extubation increases the risk of reintubation, whereas delayed extubation increases ventilator-associated complications. The rapid shallow breathing index (RSBI) is widely used but has limited accuracy on its own. Diaphragm ultrasound, including diaphragm thickening fraction (DTF), has emerged as a reliable method for assessing diaphragm function.
This prospective, observational, single-center study is conducted in the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center, Malatya, Turkey. Adult patients who have received invasive mechanical ventilation for at least 48 hours and are scheduled for a spontaneous breathing trial (SBT) are enrolled after informed consent is obtained from a legally authorized representative.
RSBI is calculated before the SBT. Right hemidiaphragm ultrasound is performed by the same investigator in all patients, who is blinded to the RSBI value and the extubation decision. DTF is measured at the beginning and at the end of the SBT, and the change in DTF between the two measurements is calculated. Diaphragm excursion is also recorded. The primary indication for mechanical ventilation is recorded using a predefined hierarchy.
The primary outcome is extubation success, defined as the absence of reintubation or of respiratory failure not manageable with non-invasive ventilation or high-flow oxygen therapy within 48 hours after extubation. The diagnostic performance of DTF, diaphragm excursion, and RSBI, alone and in combination will be compared using receiver operating characteristic curve analysis with the combined DTF+RSBI model derived from logistic regression. The planned sample size is 80 patients.
- Conditions
- Ventilator Weaning, Respiratory Insufficiency
- Being tested
- Diaphragm Ultrasonography, Rapid Shallow Breathing Index
- Keywords
- Diaphragm Ultrasonography, Diaphragm Thickening Fraction, Diaphragm Excursion, Rapid Shallow Breathing Index, Extubation, Spontaneous Breathing Trial, Intensive Care Unit
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm UltrasonographyDiagnostic test
Right hemidiaphragm ultrasound measuring diaphragm thickening fraction at the beginning and end of the spontaneous breathing trial, the change between the two, and diaphragm excursion. Performed by a single investigator blinded to RSBI and the extubation decision.
Rapid Shallow Breathing IndexDiagnostic test
Ratio of respiratory frequency to tidal volume (breaths/min/L) calculated before the spontaneous breathing trial.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated ICU Patients Undergoing Spontaneous Breathing Trial | Adult patients on invasive mechanical ventilation for at least 48 hours who are scheduled for a spontaneous breathing trial and extubation, undergoing diaphragm ultrasound and RSBI measurement. Receives: Diagnostic Test: Diaphragm Ultrasonography; Diagnostic Test: Rapid Shallow Breathing Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of Combined DTF and RSBI for Predicting Extubation Success
Area under the receiver operating characteristic curve (AUC) of the combined diaphragm thickening fraction and RSBI model compared with RSBI alone for predicting extubation success, defined as no reintubation and no respiratory failure unmanageable with non-invasive ventilation or high-flow oxygen therapy.
Measured: 48 hours after extubation
Secondary outcomes (9)
Diaphragm Thickening Fraction
Right hemidiaphragm thickening fraction measured by ultrasonography, calculated as (end-inspiratory thickness minus end-expiratory thickness) divided by end-expiratory thickness, expressed as a percentage.
Measured: At the beginning and at the end of the spontaneous breathing trial
Change in Diaphragm Thickening Fraction During the Spontaneous Breathing Trial
Difference between diaphragm thickening fraction measured at the end and at the beginning of the spontaneous breathing trial, in percentage points.
Measured: From the beginning to the end of the spontaneous breathing trial
Diaphragm Excursion
Right hemidiaphragm excursion measured by M-mode ultrasonography, in centimeters.
Measured: At the end of the spontaneous breathing trial
Rapid Shallow Breathing Index
Ratio of respiratory frequency to tidal volume, in breaths/min/L.
Measured: Before the spontaneous breathing trial
Hospital Mortality
Number of participants who died from any cause during the hospital stay.
Measured: From extubation up to 28 days
ICU Length of Stay
Length of intensive care unit stay, in days.
Measured: From ICU admission to ICU discharge, assessed up to 28 days
Hospital Length of Stay
Total length of hospital stay, in days.
Measured: From hospital admission to hospital discharge, assessed up to 28 days
Reintubation Within 7 Days
Proportion of patients requiring reintubation within 7 days after extubation.
Measured: 7 days after extubation
ICU Mortality
Number of participants who died from any cause during the intensive care unit stay.
Measured: From extubation up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (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.
- More trials run by Inonu 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
- Investigators
- Ayşe Belin Özer, MD, Prof., Principal investigator, Intensive Care Unit, Inonu University turgut Ozal Medical Center,Malatya, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897617
- Sponsor's protocol ID
- 10845
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and the absence of consent for data sharing beyond the study team. Aggregate results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Combining Diaphragm Thickening Fraction and Rapid Shallow Breathing Index in Predicting Extubation Success in Intensive Care Unit Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07897617
- Acronym / sponsor ID
- 10845
- Conditions
- Ventilator Weaning, Respiratory Insufficiency
- Keywords
- Diaphragm Ultrasonography, Diaphragm Thickening Fraction, Diaphragm Excursion, Rapid Shallow Breathing Index, Extubation, Spontaneous Breathing Trial, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 27 Oct 2026 (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 purpose of this study is to find out whether diaphragm ultrasound measurements, alone or combined with the rapid shallow breathing index (RSBI), can better predict successful removal of the breathing tube in adult intensive care unit patients on mechanical ventilation. Diaphragm thickening fraction and diaphragm excursion are measured with bedside ultrasound during the spontaneous breathing trial. Patients are followed after extubation to determine whether they need to be reintubated. The study does not change patient treatment; all measurements are non-invasive.
Detailed description
Weaning from mechanical ventilation is a critical phase of intensive care. Premature extubation increases the risk of reintubation, whereas delayed extubation increases ventilator-associated complications. The rapid shallow breathing index (RSBI) is widely used but has limited accuracy on its own. Diaphragm ultrasound, including diaphragm thickening fraction (DTF), has emerged as a reliable method for assessing diaphragm function.
This prospective, observational, single-center study is conducted in the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center, Malatya, Turkey. Adult patients who have received invasive mechanical ventilation for at least 48 hours and are scheduled for a spontaneous breathing trial (SBT) are enrolled after informed consent is obtained from a legally authorized representative.
RSBI is calculated before the SBT. Right hemidiaphragm ultrasound is performed by the same investigator in all patients, who is blinded to the RSBI value and the extubation decision. DTF is measured at the beginning and at the end of the SBT, and the change in DTF between the two measurements is calculated. Diaphragm excursion is also recorded. The primary indication for mechanical ventilation is recorded using a predefined hierarchy.
The primary outcome is extubation success, defined as the absence of reintubation or of respiratory failure not manageable with non-invasive ventilation or high-flow oxygen therapy within 48 hours after extubation. The diagnostic performance of DTF, diaphragm excursion, and RSBI, alone and in combination will be compared using receiver operating characteristic curve analysis with the combined DTF+RSBI model derived from logistic regression. The planned sample size is 80 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated ICU Patients Undergoing Spontaneous Breathing Trial | – | Diagnostic Test: Diaphragm Ultrasonography, Diagnostic Test: Rapid Shallow Breathing IndexAdult patients on invasive mechanical ventilation for at least 48 hours who are scheduled for a spontaneous breathing trial and extubation, undergoing diaphragm ultrasound and RSBI measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving invasive mechanical ventilation in the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center who are scheduled for a spontaneous breathing trial.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Invasive mechanical ventilation via an orotracheal or nasotracheal tube for at least 48 hours
- Planned spontaneous breathing trial
- Meeting weaning criteria with a clinical decision for extubation
- Informed consent obtained from a legally authorized representative
Key exclusion criteria (12 listed)
- Diaphragm paralysis
- Neuromuscular disease
- High cervical spinal cord injury
- Pregnancy
- Inadequate ultrasound image quality
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 |
|---|---|---|
| Diaphragm UltrasonographyRight hemidiaphragm ultrasound measuring diaphragm thickening fraction at the beginning and end of the spontaneous breathing trial, the change between the two, and diaphragm excursion. Performed by a single investigator blinded to RSBI and the extubation decision. | Diagnostic test | Mechanically Ventilated ICU Patients Undergoing Spontaneous Breathing Trial |
| Rapid Shallow Breathing IndexRatio of respiratory frequency to tidal volume (breaths/min/L) calculated before the spontaneous breathing trial. | Diagnostic test | Mechanically Ventilated ICU Patients Undergoing Spontaneous Breathing Trial |
Primary outcome
Diagnostic Performance of Combined DTF and RSBI for Predicting Extubation Success
Time frame: 48 hours after extubation
Area under the receiver operating characteristic curve (AUC) of the combined diaphragm thickening fraction and RSBI model compared with RSBI alone for predicting extubation success, defined as no reintubation and no respiratory failure unmanageable with non-invasive ventilation or high-flow oxygen therapy.
9 secondary outcomes
Diaphragm Thickening Fraction
Time frame: At the beginning and at the end of the spontaneous breathing trial
Change in Diaphragm Thickening Fraction During the Spontaneous Breathing Trial
Time frame: From the beginning to the end of the spontaneous breathing trial
Diaphragm Excursion
Time frame: At the end of the spontaneous breathing trial
Rapid Shallow Breathing Index
Time frame: Before the spontaneous breathing trial
Hospital Mortality
Time frame: From extubation up to 28 days
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, assessed up to 28 days
Hospital Length of Stay
Time frame: From hospital admission to hospital discharge, assessed up to 28 days
Reintubation Within 7 Days
Time frame: 7 days after extubation
ICU Mortality
Time frame: From extubation up to 28 days
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and the absence of consent for data sharing beyond the study team. Aggregate results will be published in a peer-reviewed journal.
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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.
Ayşe Belin Özer, MD, Prof. principal investigator
Intensive Care Unit, Inonu University turgut Ozal Medical Center,Malatya, Türkiye
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Weaning and Respiratory Insufficiency, run by Inonu 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 5 inclusion and 12 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 27 Oct 2026. 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 Göksel Aydoğan, MD (+905342428048, drgoksel5533@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Combined DTF and RSBI for Predicting Extubation Success (time frame: 48 hours 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 27 Oct 2026.