Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07073976

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

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTTransthoracic Echocardiography (TTE)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.

Timeline

Start date
2025-07-31
Primary completion
2026-07-15
Completion
2026-07-16
First posted
2025-07-20
Last updated
2025-09-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07073976. Inclusion in this directory is not an endorsement.

Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit (NCT07073976) · Clinical Trials Directory