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Determining the appropriate extubation timing for mechanically ventilated patients is a critical issue in the Intensive Care Unit (ICU). Early or delayed extubation may prolong mechanical ventilation and ICU stay, leading to an increased mortality rate. Currently, extubation timing relies solely on the Spontaneous Breathing Trial (SBT), but its reliability is relatively low, with a extubation failure rate ranging from 10% to 40%. Therefore, accurately predicting potential post-extubation issues and early identification of reasons for SBT trial failure are crucial for improving patient outcomes. Commonly used parameters for assessing readiness for extubation do not fully reflect organ dysfunction, and the investigators plan to utilize comprehensive techniques, including bedside lung and diaphragm ultrasound parameters, to enhance the accuracy of predicting extubation outcomes in patients who pass the SBT trial.
All patients included in the study underwent a spontaneous breathing trial (SBT) using pressure support ventilation (PSV) strategy. This strategy employed pressure support(PS)≤9 cmH2O and positive end-expiratory pressure (PEEP)≤5 cmH2O. The duration of the trial was 30 minutes, and the FiO2 level was set at the same level (≤0.5) used during mechanical ventilation. After successful completion of the spontaneous breathing trial (SBT), ultrasound images were promptly acquired, and the Rapid Shallow Breathing Index (RSBI) was calculated based on the values displayed by the ventilator . Simultaneously, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score was computed and recorded. The decision to extubate, made by the attending physician (unaware of the ultrasound examination parameters), was based on clinical judgment. The primary endpoint event was extubation failure, defined as successful completion of SBT but an inability to sustain spontaneous breathing for more than 48 hours without noninvasive or invasive ventilation support.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extubation Success Group | Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation. | ||
| Extubation Failure Group | Extubation failure is defined as successful Spontaneous Breathing Trial (SBT) but an inability to sustain independent breathing for more than 48 hours without non-invasive or invasive ventilation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful Removal of Endotracheal Tube | Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation. | The patient undergoes a spontaneous breathing trial, and measurements are taken 30 minutes after the removal of the endotracheal tube. |
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Inclusion Criteria:
Exclusion Criteria:
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From September 01, 2022, to December 30, 2024, continuously enroll patients admitted to both ICU and EICU who, due to various pathophysiological reasons, require mechanical ventilation for more than 24 hours and have successfully passed a spontaneous breathing trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, Master | Contact | +8617751500920 | 17751500920@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jun Liu, Master | Affiliated Hospital of Jiangnan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangnan University | Recruiting | Wuxi | Jiangsu | 214122 | China |
Within 60 days of publication, we will share research data, including but not limited to the Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), and Analytic Code. The aforementioned research data will be uploaded in the form of case record sheets to https://github.com/.
within 60 days of publication
individual patient data(IPD) Sharing Standards
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Data is solely for lawful, scientific research, not commercial or illegal use.
Compliance:
Usage complies with regulations, ethics, privacy principles.
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Utilizing researchers submit detailed proposals.
Ethical Review:
Proposals need ethics committee approval.
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Researchers ensure secure data handling.
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Data provided is de-identified for privacy.
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Researchers report progress and share results.
Sharing Plan Updates:
Data providers can update plans.
Collaboration Opportunities:
Data providers may collaborate on analysis, publications.
Legal Responsibilities:
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