PneumoniaNCT07405567
Ultrasound Evaluation of Respiratory Muscles During Mechanical Ventilation Weaning in ICU Patients
An observational study of Pneumonia and Invasive Mechanical Ventilation, run by Bursa Sevket Yilmaz Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Invasive Mechanical Ventilation, Weaning From Mechanical Ventilation in Care Unit
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Feb 2027
- 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 adult patients aged 18 years and older who are admitted to the intensive care unit with pneumonia and require invasive mechanical ventilation via endotracheal intubation. Patients are followed prospectively during the weaning process from mechanical ventilation and undergo serial bedside ultrasonographic assessment of respiratory muscles as part of observational data collection. All patients receive standard intensive care management as determined by the treating clinical team.
Who may be able to join
- Age ≥ 18 years
- Admission to the intensive care unit with a diagnosis of pneumonia
- Receiving invasive mechanical ventilation via endotracheal intubation
- Expected to undergo a weaning process from mechanical ventilation
- Written informed consent obtained from the patient or legally authorized representative
Who cannot join
- Known neuromuscular disease affecting respiratory muscles
- High cervical spinal cord injury
- History of major neck, thoracic, or diaphragmatic surgery
- Acute thoracic trauma or pneumothorax
- Central nervous system pathology affecting respiratory drive
- Continuous neuromuscular blocking agent use
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Principal Investigator
Bursa
Principal Investigator, +90 541 975 0407, gurcanguler.45@gmail.com
About this study
Official title: Ultrasonographic Evaluation of Diaphragm and Accessory Respiratory Muscles During Weaning in ICU Patients With Pneumonia
Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Failure of weaning is associated with longer ventilation duration, prolonged ICU stay, and increased risk of complications and death. Therefore, simple and reliable bedside tools are needed to better understand respiratory muscle function and to help predict weaning outcomes.
This prospective, observational, single-center study aims to evaluate respiratory muscle function using bedside ultrasound in adult ICU patients with pneumonia receiving invasive mechanical ventilation. The diaphragm, parasternal intercostal muscles, and anterior scalene muscles will be assessed using ultrasound during the weaning process. Measurements will be performed serially, starting from the first day when patients demonstrate meaningful spontaneous breathing effort and continuing until successful extubation, tracheostomy, or ICU mortality.
Ultrasound measurements of muscle thickness and thickening fraction will be analyzed in relation to weaning outcomes. In addition, ventilator parameters and commonly used weaning indices will be recorded at the time of each ultrasound assessment. The findings of this study are expected to improve understanding of respiratory muscle involvement during weaning and may contribute to earlier identification of patients at risk of weaning failure.
Read the detailed description
This study is designed as a prospective, observational, single-center cohort study conducted in the intensive care unit (ICU). Adult patients (≥18 years) admitted to the ICU with pneumonia and receiving invasive mechanical ventilation via endotracheal intubation will be eligible for inclusion. Patients with known neuromuscular diseases, high cervical spinal cord injury, prior major neck, thoracic, or diaphragmatic surgery, acute thoracic trauma, pneumothorax, central nervous system pathology, or those receiving continuous neuromuscular blockade will be excluded.
Patients will be followed from ICU admission until one of the following outcomes occurs: successful extubation, tracheostomy, or ICU mortality. The first 24 hours after ICU admission will be defined as ICU Day 1. Disease severity and baseline characteristics will be assessed on ICU Day 1 using the APACHE II, SOFA, frailty index, and Charlson Comorbidity Index scores. Sedation level will be evaluated daily using the Richmond Agitation-Sedation Scale (RASS).
The first day on which the patient demonstrates meaningful spontaneous breathing effort, defined as a RASS score of -3 or higher, will be designated as Measurement Day 0. Ultrasonographic assessments of respiratory muscles will be performed daily for the first three days starting from Measurement Day 0 and every 48 hours thereafter until extubation or another study endpoint is reached. Days with deep sedation (RASS -4 or -5) will be recorded, and only structural muscle thickness measurements will be obtained on those days.
All ultrasound measurements will be performed at the bedside in the supine position under standardized conditions. Ventilator settings will be kept unchanged for at least 30 minutes prior to measurements, and no airway suctioning or position changes will occur within 15 minutes before data acquisition. For each parameter, measurements will be averaged over three consecutive respiratory cycles obtained during a stable ventilation period.
Diaphragm assessment will be performed on the right hemidiaphragm using a low-frequency convex probe at the zone of apposition between the 9th and 10th intercostal spaces along the anterior axillary line. End-expiratory diaphragm thickness will be recorded on all measurement days. On days with RASS ≥ -3, end-inspiratory thickness will also be measured, and diaphragm thickening fraction will be calculated.
Parasternal intercostal muscles will be evaluated using a high-frequency linear probe at the right second and third intercostal spaces along the parasternal line. End-expiratory thickness will be measured on all days, and thickening fraction will be calculated on days with adequate spontaneous breathing effort.
Anterior scalene muscle assessment will be performed using a linear probe at the C6 level, positioned deep to the sternocleidomastoid muscle and lateral to the carotid artery. End-expiratory thickness will be measured daily, and thickening fraction will be calculated on days with RASS ≥ -3.
During each ultrasound session, ventilator mode, pressure support (if applicable), positive end-expiratory pressure (PEEP), fraction of inspired oxygen (FiO₂), respiratory rate, tidal volume, minute ventilation, and peripheral oxygen saturation will be recorded simultaneously. When available, indices reflecting respiratory drive and inspiratory muscle strength, including P0.1, negative inspiratory force (NIF), rapid shallow breathing index (RSBI), and the compliance-rate-oxygenation-pressure (CROP) index, will also be documented. Intra-abdominal pressure will be measured using the intravesical technique at predefined time points.
Ultrasonographic respiratory muscle parameters and their temporal changes will be analyzed in relation to weaning outcomes, with the aim of identifying markers associated with weaning failure.
- Conditions
- Pneumonia, Invasive Mechanical Ventilation, Weaning From Mechanical Ventilation in Care Unit, Respiratory Muscle Dysfunction
- Being tested
- No intervention (observational study)
- Keywords
- Mechanical Ventilation Weaning, Respiratory Muscle Ultrasound, Diaphragm Ultrasound, Parasternal Intercostal Muscle, Anterior Scalene Muscle
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational study with no assigned therapeutic intervention. Serial ultrasonographic assessments of respiratory muscles are performed for observational and data collection purposes only, and all clinical care and weaning decisions are made by the treating intensive care unit team according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia ICU Patients on Invasive Mechanical Ventilation | This cohort includes adult intensive care unit patients admitted with pneumonia who are receiving invasive mechanical ventilation via endotracheal intubation. All participants will undergo serial bedside ultrasonographic assessments of the diaphragm, parasternal intercostal muscles, and anterior scalene muscles during the weaning process. No therapeutic intervention is assigned as part of the study, and all clinical management decisions, including ventilator settings and weaning strategies, are determined by the treating ICU team according to standard care. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning Failure
Weaning failure is defined as the need for reintubation within 72 hours after planned extubation, requirement for tracheostomy, or death occurring in the intensive care unit before successful liberation from invasive mechanical ventilation.
Measured: From Measurement Day 0 until ICU discharge, up to 72 hours after extubation
Secondary outcomes (5)
Diaphragm Thickening Fraction (TFdi)
Diaphragm thickening fraction calculated from end-expiratory and end-inspiratory diaphragm thickness measurements obtained by bedside ultrasound on days with meaningful spontaneous breathing effort (RASS ≥ -3).
Measured: From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
Parasternal Intercostal Muscle Thickening Fraction (TFic)
Parasternal intercostal muscle thickening fraction measured by ultrasound at the right second and third intercostal spaces on days with adequate spontaneous breathing effort (RASS ≥ -3).
Measured: From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
Anterior Scalene Muscle Thickening Fraction (STF)
Anterior scalene muscle thickening fraction assessed by bedside ultrasound at the C6 level on days with meaningful spontaneous breathing effort (RASS ≥ -3).
Measured: From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
Respiratory Drive and Weaning Indices
Commonly used weaning and respiratory drive parameters including P0.1, negative inspiratory force (NIF), rapid shallow breathing index (RSBI), and CROP index recorded concurrently with ultrasound assessments when available.
Measured: From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.
Ventilator Parameters During Weaning
Ventilator-related parameters including ventilator mode, pressure support, positive end-expiratory pressure (PEEP), fraction of inspired oxygen (FiO₂), respiratory rate, tidal volume, minute ventilation, and peripheral oxygen saturation recorded at the time of each ultrasound evaluation.
Measured: From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed 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 posted12 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gürcan Güler, Bursa Sevket Yilmaz Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405567
- Sponsor's protocol ID
- 2024-TBEK 2026/01-03
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Feb 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 privacy considerations and the absence of a predefined data-sharing agreement for this single-center observational study.
Publications
Bhattacharya D, Esquinas AM, Mandal M. Parasternal Intercostal Muscle Thickness Fraction (PICTF%): Ultrasound a New Tool for Weaning Prediction? Indian J Crit Care Med. 2024 Apr;28(4):404. doi: 10.5005/jp-journals-10071-24665.
PubMed 38585317Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
PubMed 24949192Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Diaphragm and Accessory Respiratory Muscles During Weaning in ICU Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT07405567
- Acronym / sponsor ID
- 2024-TBEK 2026/01-03
- Conditions
- Pneumonia, Invasive Mechanical Ventilation, Weaning From Mechanical Ventilation in Care Unit, Respiratory Muscle Dysfunction
- Keywords
- Mechanical Ventilation Weaning, Respiratory Muscle Ultrasound, Diaphragm Ultrasound, Parasternal Intercostal Muscle, Anterior Scalene Muscle
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research HospitalOther government
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 12 Feb 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.
Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Failure of weaning is associated with longer ventilation duration, prolonged ICU stay, and increased risk of complications and death. Therefore, simple and reliable bedside tools are needed to better understand respiratory muscle function and to help predict weaning outcomes.
This prospective, observational, single-center study aims to evaluate respiratory muscle function using bedside ultrasound in adult ICU patients with pneumonia receiving invasive mechanical ventilation. The diaphragm, parasternal intercostal muscles, and anterior scalene muscles will be assessed using ultrasound during the weaning process. Measurements will be performed serially, starting from the first day when patients demonstrate meaningful spontaneous breathing effort and continuing until successful extubation, tracheostomy, or ICU mortality.
Ultrasound measurements of muscle thickness and thickening fraction will be analyzed in relation to weaning outcomes. In addition, ventilator parameters and commonly used weaning indices will be recorded at the time of each ultrasound assessment. The findings of this study are expected to improve understanding of respiratory muscle involvement during weaning and may contribute to earlier identification of patients at risk of weaning failure.
Detailed description
This study is designed as a prospective, observational, single-center cohort study conducted in the intensive care unit (ICU). Adult patients (≥18 years) admitted to the ICU with pneumonia and receiving invasive mechanical ventilation via endotracheal intubation will be eligible for inclusion. Patients with known neuromuscular diseases, high cervical spinal cord injury, prior major neck, thoracic, or diaphragmatic surgery, acute thoracic trauma, pneumothorax, central nervous system pathology, or those receiving continuous neuromuscular blockade will be excluded.
Patients will be followed from ICU admission until one of the following outcomes occurs: successful extubation, tracheostomy, or ICU mortality. The first 24 hours after ICU admission will be defined as ICU Day 1. Disease severity and baseline characteristics will be assessed on ICU Day 1 using the APACHE II, SOFA, frailty index, and Charlson Comorbidity Index scores. Sedation level will be evaluated daily using the Richmond Agitation-Sedation Scale (RASS).
The first day on which the patient demonstrates meaningful spontaneous breathing effort, defined as a RASS score of -3 or higher, will be designated as Measurement Day 0. Ultrasonographic assessments of respiratory muscles will be performed daily for the first three days starting from Measurement Day 0 and every 48 hours thereafter until extubation or another study endpoint is reached. Days with deep sedation (RASS -4 or -5) will be recorded, and only structural muscle thickness measurements will be obtained on those days.
All ultrasound measurements will be performed at the bedside in the supine position under standardized conditions. Ventilator settings will be kept unchanged for at least 30 minutes prior to measurements, and no airway suctioning or position changes will occur within 15 minutes before data acquisition. For each parameter, measurements will be averaged over three consecutive respiratory cycles obtained during a stable ventilation period.
Diaphragm assessment will be performed on the right hemidiaphragm using a low-frequency convex probe at the zone of apposition between the 9th and 10th intercostal spaces along the anterior axillary line. End-expiratory diaphragm thickness will be recorded on all measurement days. On days with RASS ≥ -3, end-inspiratory thickness will also be measured, and diaphragm thickening fraction will be calculated.
Parasternal intercostal muscles will be evaluated using a high-frequency linear probe at the right second and third intercostal spaces along the parasternal line. End-expiratory thickness will be measured on all days, and thickening fraction will be calculated on days with adequate spontaneous breathing effort.
Anterior scalene muscle assessment will be performed using a linear probe at the C6 level, positioned deep to the sternocleidomastoid muscle and lateral to the carotid artery. End-expiratory thickness will be measured daily, and thickening fraction will be calculated on days with RASS ≥ -3.
During each ultrasound session, ventilator mode, pressure support (if applicable), positive end-expiratory pressure (PEEP), fraction of inspired oxygen (FiO₂), respiratory rate, tidal volume, minute ventilation, and peripheral oxygen saturation will be recorded simultaneously. When available, indices reflecting respiratory drive and inspiratory muscle strength, including P0.1, negative inspiratory force (NIF), rapid shallow breathing index (RSBI), and the compliance-rate-oxygenation-pressure (CROP) index, will also be documented. Intra-abdominal pressure will be measured using the intravesical technique at predefined time points.
Ultrasonographic respiratory muscle parameters and their temporal changes will be analyzed in relation to weaning outcomes, with the aim of identifying markers associated with weaning failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumonia ICU Patients on Invasive Mechanical Ventilation | – | Other: No intervention (observational study)This cohort includes adult intensive care unit patients admitted with pneumonia who are receiving invasive mechanical ventilation via endotracheal intubation. All participants will undergo serial bedside ultrasonographic assessments of the diaphragm, parasternal intercostal muscles, and anterior scalene muscles during the weaning process. No therapeutic intervention is assigned as part of the study, and all clinical management decisions, including ventilator settings and weaning strategies, are determined by the treating ICU team according to standard care. |
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 adult patients aged 18 years and older who are admitted to the intensive care unit with pneumonia and require invasive mechanical ventilation via endotracheal intubation. Patients are followed prospectively during the weaning process from mechanical ventilation and undergo serial bedside ultrasonographic assessment of respiratory muscles as part of observational data collection. All patients receive standard intensive care management as determined by the treating clinical team.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Admission to the intensive care unit with a diagnosis of pneumonia
- Receiving invasive mechanical ventilation via endotracheal intubation
- Expected to undergo a weaning process from mechanical ventilation
- Written informed consent obtained from the patient or legally authorized representative
Key exclusion criteria (7 listed)
- Known neuromuscular disease affecting respiratory muscles
- High cervical spinal cord injury
- History of major neck, thoracic, or diaphragmatic surgery
- Acute thoracic trauma or pneumothorax
- Central nervous system pathology affecting respiratory drive
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 |
|---|---|---|
| No intervention (observational study)This is an observational study with no assigned therapeutic intervention. Serial ultrasonographic assessments of respiratory muscles are performed for observational and data collection purposes only, and all clinical care and weaning decisions are made by the treating intensive care unit team according to standard practice. | Other | Pneumonia ICU Patients on Invasive Mechanical Ventilation |
Primary outcome
Weaning Failure
Time frame: From Measurement Day 0 until ICU discharge, up to 72 hours after extubation
Weaning failure is defined as the need for reintubation within 72 hours after planned extubation, requirement for tracheostomy, or death occurring in the intensive care unit before successful liberation from invasive mechanical ventilation.
5 secondary outcomes
Diaphragm Thickening Fraction (TFdi)
Time frame: From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
Parasternal Intercostal Muscle Thickening Fraction (TFic)
Time frame: From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
Anterior Scalene Muscle Thickening Fraction (STF)
Time frame: From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
Respiratory Drive and Weaning Indices
Time frame: From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.
Ventilator Parameters During Weaning
Time frame: From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed 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 12 Feb 2026.
- Results publication: PubMed 38585317Bhattacharya D, Esquinas AM, Mandal M. Parasternal Intercostal Muscle Thickness Fraction (PICTF%): Ultrasound a New Tool for Weaning Prediction? Indian J Crit Care Med. 2024 Apr;28(4):404. doi: 10.5005/jp-journals-10071-24665.
- Results publication: PubMed 24949192Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
- Results publication: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy considerations and the absence of a predefined data-sharing agreement for this single-center observational study.
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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.
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 Pneumonia and Invasive Mechanical Ventilation, run by Bursa Sevket Yilmaz 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 5 inclusion and 7 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 12 Feb 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?
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 Gürcan Güler (+90 541 975 0407, gurcanguler.45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning Failure (time frame: From Measurement Day 0 until ICU discharge, up to 72 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07405567, which also lists 3 linked publications.
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 12 Feb 2026.