NCT07073976

Brief Summary

The goal of this prospective observational study is to evaluate whether right ventricular (RV) function parameters assessed via transthoracic echocardiography (TTE) can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are: Can the TAPSE (Tricuspid Annular Plane Systolic Excursion) value predict successful extubation? Do other right heart parameters (tricuspid S', RV-FAC, right atrial area, pulmonary valve acceleration time) provide additional prognostic value for weaning outcomes? Participants will: Be adult ICU patients planned for weaning from mechanical ventilation. Undergo transthoracic echocardiography within 2 hours after meeting clinical weaning criteria. Have the following echocardiographic parameters measured: TAPSE, tricuspid S', RV-FAC, right atrial area, and pulmonary valve acceleration time. Be monitored for 24 hours after extubation to assess weaning success (defined as no need for reintubation, non-invasive ventilation, or high-flow oxygen support).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

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)

  • Discriminative Ability of TAPSE for Predicting Weaning Success

    Assessment of the predictive accuracy of TAPSE (Tricuspid Annular Plane Systolic Excursion) in identifying weaning success, defined as no requirement for reintubation, non-invasive ventilation, or high-flow oxygen within 24 hours post-extubation.

    Within 24 hours after extubation

Secondary Outcomes (4)

  • Discriminative Ability of RV-FAC in Predicting Weaning Success

    Within 24 hours after extubation

  • Discriminative Ability of Tricuspid S' Velocity in Predicting Weaning Success

    Within 24 hours after extubation

  • Correlation of Right Atrial Area With Weaning Outcome

    Within 24 hours after extubation

  • Correlation of Pulmonary Valve Acceleration Time with Predicting Weaning Success

    Within 24 hours after extubation

Study Arms (1)

Mechanically Ventilated ICU Patients Undergoing Weaning

Adult patients receiving mechanical ventilation in the intensive care unit (ICU) who meet clinical criteria for planned weaning and extubation. All patients will undergo bedside transthoracic echocardiography (TTE) to assess right ventricular function prior to extubation.

Diagnostic Test: Transthoracic Echocardiography (TTE)

Interventions

Non-invasive ultrasound imaging of the heart to evaluate right ventricular and right atrial function using parameters such as TAPSE, tricuspid S', RV-FAC, right atrial area, and pulmonary valve acceleration time. TTE will be performed once within 2 hours prior to extubation decision as part of routine care.

Mechanically Ventilated ICU Patients Undergoing Weaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who are receiving invasive mechanical ventilation in the intensive care unit (ICU) and are scheduled for planned extubation based on standard clinical weaning criteria. All participants must be hemodynamically stable and able to undergo transthoracic echocardiographic assessment prior to extubation.

You may qualify if:

  • Receiving invasive mechanical ventilation in the ICU
  • Planned extubation (weaning) according to standard clinical criteria
  • Hemodynamically stable at the time of transthoracic echocardiography (TTE)
  • Ability to undergo echocardiographic assessment within 2 hours prior to extubation
  • Informed consent obtained from patient or legal representative

You may not qualify if:

  • Known severe tricuspid valve disease or congenital heart disease
  • Moderate to severe pericardial effusion or cardiac tamponade
  • Inadequate acoustic window for transthoracic echocardiography
  • Patients requiring urgent or unplanned extubation
  • Use of extracorporeal life support (e.g., ECMO) at the time of assessment
  • Known pulmonary embolism or acute cor pulmonale
  • Pregnancy

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

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

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