Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07073976
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Istanbul, 34303, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 hours after extubation
To assess whether right atrial area measured before extubation is associated with weaning success or failure.
Time frame: Within 24 hours after extubation
To investigate whether pulmonary valve acceleration time (PVAT), measured via transthoracic echocardiography, is associated with weaning success.
Contact information is provided by the study sponsor or research team.
Kanuni Sultan Suleyman Training and Research Hospital
Other
Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
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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