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The goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters 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 mechanical power (MP) value predict successful extubation? Do other respiratory parameters-airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)-provide additional prognostic value for weaning outcomes?
Participants will:
This is a prospective, observational, single-center study designed to investigate whether ventilator-derived physiological measurements can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of mechanical power (MP) in forecasting successful extubation.
Secondary objectives include the evaluation of additional respiratory parameters such as airway occlusion pressure (P0.1), negative inspiratory force (NIF), the rapid shallow breathing index (RSBI), and the mechanical power/negative inspiratory force ratio (MP/NIF). These parameters will be measured at the bedside within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.
All participants will be monitored for 48 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation after extubation during this period.
Data collection will include:
Respiratory measurements obtained from the ventilator: MP, P0.1, NIF, RSBI, and MP/NIF.
Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II scores, ventilator 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 ICU care. Ventilator-based respiratory assessments are routinely performed in ICU settings and pose no additional risk to participants.
The results may support the integration of load-drive-capacity assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 ventilator-based respiratory assessment to evaluate mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI) prior to extubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical power | Diagnostic Test | Non-invasive bedside evaluation of respiratory load, neural drive, and inspiratory muscle capacity using mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI). • Measurements will be performed once within 2 hours prior to the extubation decision as part of routine ICU respiratory monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Power (MP) | Mechanical Power (MP), a ventilator-derived estimate of the total mechanical energy transferred to the respiratory system per unit time, will be measured prior to planned extubation and evaluated in relation to extubation outcomes | 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Occlusion Pressure at 100 ms (P0.1) | P0.1, an indicator of the patient's neural inspiratory drive that reflects the initial negative pressure generated at the start of a breath, will be measured prior to planned extubation and evaluated in relation to extubation outcomes | 48 hour |
| Negative Inspiratory Force (NIF) |
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Inclusion Criteria:
-
Age ≥ 18 years (adult patient population)
Exclusion Criteria:
and
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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 bedside ventilator-based respiratory assessment, including mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI), prior to extubation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital | Istanbul | 34303 | Turkey (Türkiye) |
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|
NIF, a measure of maximal inspiratory muscle strength reflecting the patient's ability to generate negative pressure, will be obtained prior to planned extubation and evaluated in relation to extubation outcomes |
| 48 hour |
| Rapid Shallow Breathing Index (RSBI) | RSBI, an established index that incorporates respiratory rate and tidal volume to characterize rapid and shallow breathing, will be recorded prior to planned extubation and evaluated in relation to extubation outcomes | 48 hour |
| Mechanical Power to Negative Inspiratory Force Ratio (MP/NIF Ratio) | The MP/NIF ratio, reflecting the relationship between ventilatory mechanical load and inspiratory muscle capacity, will be calculated prior to planned extubation and evaluated in relation to extubation outcomes | 48 hour |