Weaning Failure of Mechanical VentilationNCT07075926
Evaluation of Left Ventricular Function to Predict Weaning Success in the Intensive Care Unit
An observational study of Weaning Failure of Mechanical Ventilation, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective observational study is to evaluate whether left ventricular function parameters assessed via transthoracic echocardiography (TTE) can predict weaning success from mechanical ventilation in adult intensive care unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure of Mechanical Ventilation
- What is being tested?
- Echocardiographic Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2025to 16 Jul 2026
- How long will I take part?
- 1 Day
- 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 will consist of adult patients admitted to the intensive care unit (ICU) who are receiving invasive mechanical ventilation and are scheduled for extubation after fulfilling standard weaning criteria. All participants will be hemodynamically stable at the time of echocardiographic assessment. Patients with significant structural heart disease, inadequate echocardiographic imaging windows, or ongoing extracorporeal support will be excluded. The population represents a typical critically ill cohort undergoing weaning from mechanical ventilation.
Who may be able to join
- Currently receiving mechanical ventilation in the ICU
- Planned extubation after meeting standard weaning criteria
- Hemodynamically stable at the time of echocardiographic evaluation
- Written informed consent obtained from the patient or legally authorized representative
Who cannot join
- Surgery within the previous 24 hours
- Presence of significant valvular heart disease or known cardiomyopathy
- Inadequate acoustic window for transthoracic echocardiography
- Ongoing use of extracorporeal support (e.g., ECMO)
- Patients with Do-Not-Resuscitate (DNR) orders or expected to die within 24 hours
- Re-intubation planned prophylactically regardless of clinical status
- Pregnant patients
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, 1 recruiting
- Recruiting
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
Engin ihsan Turan, Principal investigator, 05382431114, enginihsan@hotmail.com
About this study
Official title: Evaluation of Left Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
The goal of this prospective observational study is to evaluate whether left ventricular function parameters assessed via transthoracic echocardiography (TTE) can predict weaning success from mechanical ventilation in adult intensive care unit (ICU) patients. The main questions it aims to answer are:
Can the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) predict successful extubation?
Read more
What is the prognostic value of other echocardiographic measures such as Mitral Annular Plane Systolic Excursion (MAPSE), E/e' ratio, E/A ratio, Mitral Deceleration Time (MDT), and Myocardial Performance Index (Tei index) in forecasting weaning outcomes?
Participants will:
Be adults receiving mechanical ventilation and scheduled for weaning
Undergo transthoracic echocardiography (TTE) within 2 hours after meeting weaning criteria
Have the following parameters measured: LVOT VTI, MAPSE, E/e', E/A, MDT, and Tei index
Be monitored for 24 hours post-extubation to determine if they remain off ventilatory support, including reintubation, non-invasive ventilation, or high-flow oxygen therapy
This study aims to provide a comprehensive understanding of how systolic, diastolic, and global cardiac functions influence extubation success, potentially improving ICU decision-making and reducing complications, length of stay, and healthcare costs.
Read the detailed description
This prospective, single-center observational study aims to assess the predictive value of left ventricular function parameters obtained via transthoracic echocardiography (TTE) in determining weaning success in mechanically ventilated adult ICU patients.
Following fulfillment of weaning criteria, patients will undergo TTE evaluation within 2 hours. The echocardiographic assessment will include the measurement of:
Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Mitral Annular Plane Systolic Excursion (MAPSE)
E/e' ratio
E/A ratio
Mitral Deceleration Time (MDT)
Myocardial Performance Index (Tei index)
These measurements aim to reflect systolic, diastolic, and global left ventricular functions. After the echocardiographic assessment, patients will be followed for 24 hours to determine weaning success, defined as the ability to maintain spontaneous breathing without reintubation, non-invasive ventilation, or high-flow oxygen support.
By integrating non-invasive, bedside cardiac function assessments into the extubation decision-making process, the study seeks to contribute to more physiologically guided weaning strategies. The results may help reduce weaning-related complications and optimize resource use in critical care settings
- Being tested
- Echocardiographic Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic AssessmentDiagnostic test
All participants will receive a standardized transthoracic echocardiographic (TTE) examination within 2 hours after meeting weaning criteria. The following cardiac function parameters will be recorded:
LVOT Velocity Time Integral (VTI)
Mitral Annular Plane Systolic Excursion (MAPSE)
E/e' ratio
E/A ratio
Mitral Deceleration Time (MDT)
Myocardial Performance Index (Tei index)
The echocardiographic data will be used to investigate the association between left ventricular function and weaning success.
| Study group | Role | What they receive |
|---|---|---|
| Weaning Candidates | This group includes adult ICU patients who are receiving mechanical ventilation and have met standardized weaning criteria. All patients in this cohort will undergo transthoracic echocardiographic (TTE) assessment before extubation, without any experimental intervention applied. Receives: Diagnostic Test: Echocardiographic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of LVOT VTI in Determining Weaning Success
To evaluate whether the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) measured by transthoracic echocardiography (TTE) within 2 hours after fulfilling weaning criteria can predict successful weaning from mechanical ventilation. Successful weaning is defined as maintaining spontaneous breathing for at least 24 hours without requiring reintubation, non-invasive ventilation, or high-flow nasal oxygen therapy.
Measured: Within 24 hours after extubation
Secondary outcomes (1)
Predictive Value of Additional Left Ventricular Function Parameters in Weaning Success
To assess whether echocardiographic parameters other than LVOT VTI - including Mitral Annular Plane Systolic Excursion (MAPSE), E/e' ratio, E/A ratio, Mitral Deceleration Time (MDT), and Myocardial Performance Index (Tei index) - are associated with successful weaning from mechanical ventilation. These parameters reflect systolic, diastolic, and global left ventricular function and will be measured using transthoracic echocardiography prior to extubation.
Measured: Within 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start31 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion16 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Failure of 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
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075926
- Sponsor's protocol ID
- Weaning-Left Heart
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 9 Sep 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07075926
- Acronym / sponsor ID
- Weaning-Left Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 16 Jul 2026 (estimated)
- First posted
- 20 Jul 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 prospective observational study is to evaluate whether left ventricular function parameters assessed via transthoracic echocardiography (TTE) can predict weaning success from mechanical ventilation in adult intensive care unit (ICU) patients. The main questions it aims to answer are:
Can the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) predict successful extubation?
What is the prognostic value of other echocardiographic measures such as Mitral Annular Plane Systolic Excursion (MAPSE), E/e' ratio, E/A ratio, Mitral Deceleration Time (MDT), and Myocardial Performance Index (Tei index) in forecasting weaning outcomes?
Participants will:
Be adults receiving mechanical ventilation and scheduled for weaning
Undergo transthoracic echocardiography (TTE) within 2 hours after meeting weaning criteria
Have the following parameters measured: LVOT VTI, MAPSE, E/e', E/A, MDT, and Tei index
Be monitored for 24 hours post-extubation to determine if they remain off ventilatory support, including reintubation, non-invasive ventilation, or high-flow oxygen therapy
This study aims to provide a comprehensive understanding of how systolic, diastolic, and global cardiac functions influence extubation success, potentially improving ICU decision-making and reducing complications, length of stay, and healthcare costs.
Detailed description
This prospective, single-center observational study aims to assess the predictive value of left ventricular function parameters obtained via transthoracic echocardiography (TTE) in determining weaning success in mechanically ventilated adult ICU patients.
Following fulfillment of weaning criteria, patients will undergo TTE evaluation within 2 hours. The echocardiographic assessment will include the measurement of:
Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Mitral Annular Plane Systolic Excursion (MAPSE)
E/e' ratio
E/A ratio
Mitral Deceleration Time (MDT)
Myocardial Performance Index (Tei index)
These measurements aim to reflect systolic, diastolic, and global left ventricular functions. After the echocardiographic assessment, patients will be followed for 24 hours to determine weaning success, defined as the ability to maintain spontaneous breathing without reintubation, non-invasive ventilation, or high-flow oxygen support.
By integrating non-invasive, bedside cardiac function assessments into the extubation decision-making process, the study seeks to contribute to more physiologically guided weaning strategies. The results may help reduce weaning-related complications and optimize resource use in critical care settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weaning Candidates | – | Diagnostic Test: Echocardiographic AssessmentThis group includes adult ICU patients who are receiving mechanical ventilation and have met standardized weaning criteria. All patients in this cohort will undergo transthoracic echocardiographic (TTE) assessment before extubation, without any experimental intervention applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients admitted to the intensive care unit (ICU) who are receiving invasive mechanical ventilation and are scheduled for extubation after fulfilling standard weaning criteria. All participants will be hemodynamically stable at the time of echocardiographic assessment. Patients with significant structural heart disease, inadequate echocardiographic imaging windows, or ongoing extracorporeal support will be excluded. The population represents a typical critically ill cohort undergoing weaning from mechanical ventilation.
Key inclusion criteria (4 listed)
- Currently receiving mechanical ventilation in the ICU
- Planned extubation after meeting standard weaning criteria
- Hemodynamically stable at the time of echocardiographic evaluation
- Written informed consent obtained from the patient or legally authorized representative
Key exclusion criteria (7 listed)
- Surgery within the previous 24 hours
- Presence of significant valvular heart disease or known cardiomyopathy
- Inadequate acoustic window for transthoracic echocardiography
- Ongoing use of extracorporeal support (e.g., ECMO)
- Patients with Do-Not-Resuscitate (DNR) orders or expected to die within 24 hours
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 |
|---|---|---|
| Echocardiographic AssessmentAll participants will receive a standardized transthoracic echocardiographic (TTE) examination within 2 hours after meeting weaning criteria. The following cardiac function parameters will be recorded: LVOT Velocity Time Integral (VTI) Mitral Annular Plane Systolic Excursion (MAPSE) E/e' ratio E/A ratio Mitral Deceleration Time (MDT) Myocardial Performance Index (Tei index) The echocardiographic data will be used to investigate the association between left ventricular function and weaning success. | Diagnostic test | Weaning Candidates |
Primary outcome
Predictive Value of LVOT VTI in Determining Weaning Success
Time frame: Within 24 hours after extubation
To evaluate whether the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) measured by transthoracic echocardiography (TTE) within 2 hours after fulfilling weaning criteria can predict successful weaning from mechanical ventilation. Successful weaning is defined as maintaining spontaneous breathing for at least 24 hours without requiring reintubation, non-invasive ventilation, or high-flow nasal oxygen therapy.
1 secondary outcome
Predictive Value of Additional Left Ventricular Function Parameters in Weaning Success
Time frame: Within 24 hours after 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 9 Sep 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.
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 Failure of Mechanical Ventilation, run by Kanuni Sultan Suleyman 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 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 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 Engin ihsan Turan, principal investigator (+905382431114, enginihsan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Value of LVOT VTI in Determining Weaning Success (time frame: Within 24 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 9 Sep 2025.