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

Not yet recruiting

• Conditions: Weaning Failure of Mechanical Ventilation

• Registration Number: NCT07073976
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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).

Detailed Description

This is a prospective, observational, single-center study designed to investigate whether transthoracic echocardiographic (TTE) assessment of right ventricular function can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of TAPSE (Tricuspid Annular Plane Systolic Excursion) in forecasting successful extubation.

Secondary objectives include the evaluation of additional echocardiographic parameters such as tricuspid annular systolic velocity (S'), right ventricular fractional area change (RV-FAC), right atrial area, and pulmonary valve acceleration time (PVAT). These parameters will be measured via bedside TTE within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.

All participants will be monitored for 24 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation, non-invasive ventilation, or high-flow oxygen therapy during this period.

Data collection will include:

Echocardiographic measurements: TAPSE, tricuspid S', RV-FAC, right atrial area, and PVAT.

Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II and SOFA scores, ventilation settings, and duration of mechanical ventilation.

Post-extubation follow-up: reintubation, non-invasive ventilation or high-flow oxygen use, SpO₂ values, blood gas analysis, and vital signs.

This study does not involve any interventions beyond standard care. Echocardiography is routinely performed in ICU settings and poses no additional risk to participants.

The results may support the integration of right heart function assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Study Start: 2025-07-15
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-23
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discriminative Ability of TAPSE for Predicting Weaning Success	Within 24 hours after extubation	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.

Secondary Outcome Measures

Name	Time	Method
Discriminative Ability of RV-FAC in Predicting Weaning Success	Within 24 hours after extubation	To determine the discriminative performance of right ventricular fractional area change (RV-FAC), measured by transthoracic echocardiography, in identifying weaning success.
Correlation of Right Atrial Area With Weaning Outcome	Within 24 hours after extubation	To assess whether right atrial area measured before extubation is associated with weaning success or failure.
Correlation of Pulmonary Valve Acceleration Time with Predicting Weaning Success	Within 24 hours after extubation	To investigate whether pulmonary valve acceleration time (PVAT), measured via transthoracic echocardiography, is associated with weaning success.
Discriminative Ability of Tricuspid S' Velocity in Predicting Weaning Success	Within 24 hours after extubation	To evaluate the ability of tricuspid annular systolic velocity (S'), obtained via tissue Doppler imaging, to discriminate between successful and unsuccessful weaning outcomes.

Trial Locations

Locations (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital; 🇹🇷 Istanbul, Turkey