NCT07075926

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2026

Last Updated

September 9, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

July 10, 2025

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

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.

    Within 24 hours after extubation

Secondary Outcomes (1)

  • Predictive Value of Additional Left Ventricular Function Parameters in Weaning Success

    Within 24 hours after extubation

Study Arms (1)

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

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.

Weaning Candidates

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Engin ihsan Turan, principal investigator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

July 31, 2025

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 16, 2026

Last Updated

September 9, 2025

Record last verified: 2025-07

Locations