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RecruitingNCT07075926Updated Sep 9, 2025

Evaluation of Left Ventricular Function to Predict Weaning Success in the Intensive Care Unit

An observational study in Weaning Failure of Mechanical Ventilation, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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

02

Conditions studied

  • Weaning Failure of Mechanical Ventilation
03

In context

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

    Diagnostic Test: Echocardiographic Assessment

Interventions

  • Diagnostic testEchocardiographic Assessment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Within 24 hours after extubation

07

Study locations

1 of 1 sites recruiting
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
    Istanbul, Istanbul 34303, Turkey (Türkiye)
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07075926
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Engin Ihsan Turan (principal investigator, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jul 20, 2025
Start date
Jul 31, 2025
Primary completion
Jul 15, 2026 (estimated)
Completion
Jul 16, 2026 (estimated)
Last update
Sep 9, 2025

Study contacts

Engin ihsan Turan, principal investigator
Contact
enginihsan@hotmail.com
+905382431114

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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