Weaning Failure of Mechanical VentilationNCT07073976
Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit
An observational study of Weaning Failure of Mechanical Ventilation, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure of Mechanical Ventilation
- What is being tested?
- Transthoracic Echocardiography (TTE)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2025to 16 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
Engin ihsan Turan, Principal investigator, 05382431114, enginihsan@hotmail.com
About this study
Official title: Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
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?
Read more
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).
Read the 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.
- Being tested
- Transthoracic Echocardiography (TTE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiography (TTE)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Transthoracic Echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after extubation
Secondary outcomes (4)
Discriminative Ability of RV-FAC in Predicting Weaning Success
To determine the discriminative performance of right ventricular fractional area change (RV-FAC), measured by transthoracic echocardiography, in identifying weaning success.
Measured: Within 24 hours after extubation
Discriminative Ability of Tricuspid S' Velocity in Predicting Weaning Success
To evaluate the ability of tricuspid annular systolic velocity (S'), obtained via tissue Doppler imaging, to discriminate between successful and unsuccessful weaning outcomes.
Measured: Within 24 hours after extubation
Correlation of Right Atrial Area With Weaning Outcome
To assess whether right atrial area measured before extubation is associated with weaning success or failure.
Measured: Within 24 hours after extubation
Correlation of Pulmonary Valve Acceleration Time with Predicting Weaning Success
To investigate whether pulmonary valve acceleration time (PVAT), measured via transthoracic echocardiography, is associated with weaning success.
Measured: Within 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start31 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion16 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Failure of Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073976
- Sponsor's protocol ID
- Weaning-Right Heart
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07073976
- Acronym / sponsor ID
- Weaning-Right Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 16 Jul 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated ICU Patients Undergoing Weaning | – | Diagnostic Test: Transthoracic Echocardiography (TTE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic 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. | Diagnostic test | Mechanically Ventilated ICU Patients Undergoing Weaning |
Primary outcome
Discriminative Ability of TAPSE for Predicting Weaning Success
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.
4 secondary outcomes
Discriminative Ability of RV-FAC in Predicting Weaning Success
Time frame: Within 24 hours after extubation
Discriminative Ability of Tricuspid S' Velocity in Predicting Weaning Success
Time frame: Within 24 hours after extubation
Correlation of Right Atrial Area With Weaning Outcome
Time frame: Within 24 hours after extubation
Correlation of Pulmonary Valve Acceleration Time with Predicting Weaning Success
Time frame: Within 24 hours after extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure of Mechanical Ventilation, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Engin ihsan Turan, principal investigator (+905382431114, enginihsan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminative Ability of TAPSE for Predicting Weaning Success (time frame: Within 24 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.