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NCT Number: NCT07075926

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

Location status: Recruiting

Location contact

Engin ihsan Turan, Principal investigator

CONTACT

[email protected]

05382431114

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Echocardiographic assessment

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Predictive Value of Additional Left Ventricular Function Parameters in Weaning Success

    Time frame: Within 24 hours after extubation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Engin ihsan Turan, principal investigator

CONTACT

[email protected]

+905382431114

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

Evaluation of Left Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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