Weaning Mechanical VentilationICUNCT07332403
The Relationship Between Diaphragm Function Assessed by Ultrasound and Weaning Success in Mechanically Ventilated Patients in the ICU
An observational study of Weaning Mechanical Ventilation and Ultrasonography, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The diaphragm is the most important muscle involved in the respiratory system and is solely responsible for approximately 65-80% of vital capacity. When it contracts, it increases the volume of the thoracic cavity, leading to a decrease in intrathoracic pressure and allowing airflow from the atmosphere into the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Mechanical Ventilation, Ultrasonography, Intensive Care (ICU)
- What is being tested?
- Diaphragm ultrasound before weaning procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Dec 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were admitted to the Intensive Care Unit of Fatih Sultan Mehmet Training and Research Hospital between March 2025 and December 2025, received invasive mechanical ventilation for at least 24 hours, and were considered ready for separation from mechanical ventilation by the intensive care physician.
Who may be able to join
- Patients who were admitted to the Intensive Care Unit of Fatih Sultan Mehmet Training and Research Hospital between March 2025 and December 2025, received invasive mechanical ventilation for at least 24 hours, and were considered ready for separation from mechanical ventilation by the intensive care physician.
- Patients aged 18 years and older.
- Patients who provided written informed consent.
Who cannot join
- Patients younger than 18 years of age.
- Patients with a tracheostomy, neuromuscular disease, diaphragmatic paralysis, or spinal cord injury above the T8 level.
- Patients with pneumothorax, pneumomediastinum, or chest wall and/or diaphragmatic injury.
- Patients for whom informed consent could not be obtained.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
The diaphragm is the most important muscle involved in the respiratory system and is solely responsible for approximately 65-80% of vital capacity. When it contracts, it increases the volume of the thoracic cavity, leading to a decrease in intrathoracic pressure and allowing airflow from the atmosphere into the alveoli. Diaphragmatic atrophy begins as early as the first hours of mechanical ventilation (MV). Animal studies have demonstrated that prolonged mechanical ventilation results in diaphragmatic dysfunction, a condition defined as ventilator-induced diaphragmatic dysfunction (VIDD). Ultrasonographic evaluation of the diaphragm has shown a 32% reduction in diaphragmatic strength within the first 72 hours.
Assessment of diaphragmatic function is crucial for predicting weaning success. Ultrasonography (USG) is a practical, safe, non-invasive, bedside method that provides real-time results and allows both morphological and functional evaluation of the diaphragm. The ability to assess diaphragmatic contraction simultaneously enables measurement and follow-up of diaphragmatic thickness. This is also clinically useful for diagnosing diaphragmatic dysfunction and diaphragmatic paralysis.
Read more
The aim of this study was to evaluate the relationship between diaphragmatic function assessed by ultrasonography and weaning success in intubated patients followed in the intensive care unit.
In patients admitted to the Intensive Care Unit who received invasive mechanical ventilation for at least 24 hours, were included in the study, were considered ready for the weaning process by the attending clinician independently of the study protocol, and had adequate cognitive function, the following parameters were measured by the investigator prior to separation from mechanical ventilation while the patient was in spontaneous breathing mode (pressure support ventilation, PSV): respiratory rate, minute ventilation, tidal volume, maximal inspiratory pressure (MIP), rapid shallow breathing index (RSBI), airway occlusion pressure at 100 ms (P0.1), PaO₂/FiO₂ ratio, PaCO₂, integrated weaning index (IWI), and static and dynamic lung compliance.
After a 30-minute stabilization period, the planned procedures were explained to the patient, and the head of the bed was elevated to 30 degrees. Using the ultrasound device routinely employed in our clinic, diaphragmatic ultrasonography was performed by an experienced clinician and the investigator. A linear probe was placed on the chest wall along the right anterior and mid-axillary lines at the 8th-9th intercostal spaces over the zone of apposition, and B-mode imaging was used to visualize the right hemidiaphragm as a three-layered structure consisting of two parallel echogenic lines (the diaphragmatic pleura and the peritoneal membrane) with a hypoechoic structure in between (the muscle itself).
Diaphragmatic thickness at end-inspiration (TEI) and end-expiration (TEE) was measured during the patient's spontaneous breathing. Three measurements were obtained, and the mean value was calculated. Using these mean values, the diaphragmatic thickening fraction (DTF) was calculated according to the formula:
DTF = [(TEI - TEE) / TEE] × 100.
Subsequently, a convex probe was placed at the right subcostal midclavicular line along the costal margin, and diaphragmatic motion was visualized using M-mode ultrasonography. Diaphragmatic excursion amplitude was measured, with three measurements obtained and the mean value recorded.
Patients who successfully completed a 30-minute spontaneous breathing trial (SBT) in PSV mode were extubated. Weaning was considered successful in patients who were able to maintain spontaneous breathing for 48 hours without mechanical ventilatory support. Patients who maintained effective spontaneous breathing without mechanical support for more than 48 hours were classified as the successful weaning group, whereas those who required reintubation and a return to mechanical ventilation at any point during the weaning process were classified as the unsuccessful weaning group.
- Conditions
- Weaning Mechanical Ventilation, Ultrasonography, Intensive Care (ICU), Assesment of Diaphragmatic Function by Ultrasound to Predict Weaning Success in Mechanical Ventilated Intensive Care Unit Patients, Diaphragm Usg
- Being tested
- Diaphragm ultrasound before weaning procedure
- Keywords
- weaning, diaphragm usg, succesful weaning, unsuccesful weaning, diaphragm excursion, ıwı
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm ultrasound before weaning procedureOther
Using the ultrasound device, diaphragmatic usg was performed by an experienced clinician and the investigator. A linear probe was placed on the chest wall along the right anterior and mid-axillary lines at the 8-9th intercostal spaces over the zone of apposition and B-mode imaging was used to visualize the right hemidiaphragm as a three-layered structure: two parallel echogenic lines with a hypoechoic layer in between. Diaphragmatic thickness at end-inspiration(TEI) and end-expiration(TEE) was measured during the patient's spontaneous breathing. Three measurements were obtained, and the mean value was calculated. The diaphragmatic thickening fraction (DTF) was then calculated using the formula. Subsequently, a convex probe was placed at the right subcostal midclavicular line along the costal margin, and diaphragmatic motion was assessed using M-mode ultrasonography.Diaphragmatic excursion amplitude was measured, with three measurements obtained and the mean value recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound assesment of Diaphragmatic function in patients undergoing weaning
Measurement of diaphragmatic thickness and diaphragmatic excursion amplitude.
Measured: Measurements were performed 30 minutes after patients were initiated on a spontaneous breathing trial following the decision to proceed with weaning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Mar 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Mechanical VentilationStudies 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
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berfin Seyrek, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332403
- Sponsor's protocol ID
- FSMICUWEAN
- Acronym
- ICU
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Diaphragm Function Assessed by Ultrasound and Weaning Success in Mechanically Ventilated Patients in the ICU
- ClinicalTrials.gov ID
- NCT07332403
- Acronym / sponsor ID
- ICU / FSMICUWEAN
- Conditions
- Weaning Mechanical Ventilation, Ultrasonography, Intensive Care (ICU), Assesment of Diaphragmatic Function by Ultrasound to Predict Weaning Success in Mechanical Ventilated Intensive Care Unit Patients, Diaphragm Usg
- Keywords
- weaning, diaphragm usg, succesful weaning, unsuccesful weaning, diaphragm excursion, ıwı
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 12 Jan 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 diaphragm is the most important muscle involved in the respiratory system and is solely responsible for approximately 65-80% of vital capacity. When it contracts, it increases the volume of the thoracic cavity, leading to a decrease in intrathoracic pressure and allowing airflow from the atmosphere into the alveoli. Diaphragmatic atrophy begins as early as the first hours of mechanical ventilation (MV). Animal studies have demonstrated that prolonged mechanical ventilation results in diaphragmatic dysfunction, a condition defined as ventilator-induced diaphragmatic dysfunction (VIDD). Ultrasonographic evaluation of the diaphragm has shown a 32% reduction in diaphragmatic strength within the first 72 hours.
Assessment of diaphragmatic function is crucial for predicting weaning success. Ultrasonography (USG) is a practical, safe, non-invasive, bedside method that provides real-time results and allows both morphological and functional evaluation of the diaphragm. The ability to assess diaphragmatic contraction simultaneously enables measurement and follow-up of diaphragmatic thickness. This is also clinically useful for diagnosing diaphragmatic dysfunction and diaphragmatic paralysis.
The aim of this study was to evaluate the relationship between diaphragmatic function assessed by ultrasonography and weaning success in intubated patients followed in the intensive care unit.
In patients admitted to the Intensive Care Unit who received invasive mechanical ventilation for at least 24 hours, were included in the study, were considered ready for the weaning process by the attending clinician independently of the study protocol, and had adequate cognitive function, the following parameters were measured by the investigator prior to separation from mechanical ventilation while the patient was in spontaneous breathing mode (pressure support ventilation, PSV): respiratory rate, minute ventilation, tidal volume, maximal inspiratory pressure (MIP), rapid shallow breathing index (RSBI), airway occlusion pressure at 100 ms (P0.1), PaO₂/FiO₂ ratio, PaCO₂, integrated weaning index (IWI), and static and dynamic lung compliance.
After a 30-minute stabilization period, the planned procedures were explained to the patient, and the head of the bed was elevated to 30 degrees. Using the ultrasound device routinely employed in our clinic, diaphragmatic ultrasonography was performed by an experienced clinician and the investigator. A linear probe was placed on the chest wall along the right anterior and mid-axillary lines at the 8th-9th intercostal spaces over the zone of apposition, and B-mode imaging was used to visualize the right hemidiaphragm as a three-layered structure consisting of two parallel echogenic lines (the diaphragmatic pleura and the peritoneal membrane) with a hypoechoic structure in between (the muscle itself).
Diaphragmatic thickness at end-inspiration (TEI) and end-expiration (TEE) was measured during the patient's spontaneous breathing. Three measurements were obtained, and the mean value was calculated. Using these mean values, the diaphragmatic thickening fraction (DTF) was calculated according to the formula:
DTF = [(TEI - TEE) / TEE] × 100.
Subsequently, a convex probe was placed at the right subcostal midclavicular line along the costal margin, and diaphragmatic motion was visualized using M-mode ultrasonography. Diaphragmatic excursion amplitude was measured, with three measurements obtained and the mean value recorded.
Patients who successfully completed a 30-minute spontaneous breathing trial (SBT) in PSV mode were extubated. Weaning was considered successful in patients who were able to maintain spontaneous breathing for 48 hours without mechanical ventilatory support. Patients who maintained effective spontaneous breathing without mechanical support for more than 48 hours were classified as the successful weaning group, whereas those who required reintubation and a return to mechanical ventilation at any point during the weaning process were classified as the unsuccessful weaning group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the Intensive Care Unit of Fatih Sultan Mehmet Training and Research Hospital between March 2025 and December 2025, received invasive mechanical ventilation for at least 24 hours, and were considered ready for separation from mechanical ventilation by the intensive care physician.
Key inclusion criteria (3 listed)
- Patients who were admitted to the Intensive Care Unit of Fatih Sultan Mehmet Training and Research Hospital between March 2025 and December 2025, received invasive mechanical ventilation for at least 24 hours, and were considered ready for separation from mechanical ventilation by the intensive care physician.
- Patients aged 18 years and older.
- Patients who provided written informed consent.
Key exclusion criteria (4 listed)
- Patients younger than 18 years of age.
- Patients with a tracheostomy, neuromuscular disease, diaphragmatic paralysis, or spinal cord injury above the T8 level.
- Patients with pneumothorax, pneumomediastinum, or chest wall and/or diaphragmatic injury.
- Patients for whom informed consent could not be obtained.
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 ultrasound before weaning procedureUsing the ultrasound device, diaphragmatic usg was performed by an experienced clinician and the investigator. A linear probe was placed on the chest wall along the right anterior and mid-axillary lines at the 8-9th intercostal spaces over the zone of apposition and B-mode imaging was used to visualize the right hemidiaphragm as a three-layered structure: two parallel echogenic lines with a hypoechoic layer in between. Diaphragmatic thickness at end-inspiration(TEI) and end-expiration(TEE) was measured during the patient's spontaneous breathing. Three measurements were obtained, and the mean value was calculated. The diaphragmatic thickening fraction (DTF) was then calculated using the formula. Subsequently, a convex probe was placed at the right subcostal midclavicular line along the costal margin, and diaphragmatic motion was assessed using M-mode ultrasonography.Diaphragmatic excursion amplitude was measured, with three measurements obtained and the mean value recorded. | Other | – |
Primary outcome
ultrasound assesment of Diaphragmatic function in patients undergoing weaning
Time frame: Measurements were performed 30 minutes after patients were initiated on a spontaneous breathing trial following the decision to proceed with weaning.
Measurement of diaphragmatic thickness and diaphragmatic excursion amplitude.
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 13 Jan 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Weaning Mechanical Ventilation and Ultrasonography, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 13 Jan 2026. 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 Turkey (Türkiye). 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?
ultrasound assesment of Diaphragmatic function in patients undergoing weaning (time frame: Measurements were performed 30 minutes after patients were initiated on a spontaneous breathing trial following the decision to proceed with weaning.). 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 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.