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Ventilator Weaning-Assisted Assessment, Non-Invasive, Continuous, Real-Time Monitoring of Pmus Waveform Technology, and Real-Time Evaluation of the Accuracy of Transpulmonary Driving Pressure

Ventilator Weaning-Assisted Assessment, Non-Invasive, Continuous, Real-Time Monitoring of Pmus Waveform Technology, and Real-Time Evaluation of the Accuracy of Transpulmonary Driving Pressure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600130929
Enrollment
Unknown
Registered
2026-08-26
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients after surgical procedures have a high risk of extubation failure due to respiratory muscle dysfunction suppression, altered pulmonary mechanics and other factors. Reintubation increases the risk of ventilator-associated pneumonia and prolongs intensive care unit (ICU) length of stay. Noninvasive measurement of muscular pressure (Pmus) enables quantitative evaluation of respiratory muscle

Interventions

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 80 years old, regardless of gender; patients admitted to the ICU with endotracheal intubation after major abdominal surgery (e.g., radical gastrectomy, hepatectomy), cardiothoracic surgery (e.g., coronary artery bypass grafting, lobectomy), or neurosurgical procedures (e.g., brain tumor resection, intracerebral hemorrhage evacuation). 2.Spontaneous breathing trial (SBT) was initiated during hospitalization, and complete SBT-related information (including SBT mode, parameter settings and SBT outcomes) was fully documented in the electronic medical records. 3.Complete Pmus monitoring data were available within 2 hours before and after the spontaneous breathing trial (SBT), including at least one record of peak Pmus before SBT and one record after SBT. Meanwhile, conventional weaning indicators (RSBI, P0.1, transpulmonary driving pressure, P/F ratio) were documented. 4.The medical records are complete, allowing traceability of extubation outcomes (success or failure) within 72 hours after extubation as well as complication information (such as pulmonary infection and causes of reintubation).

Exclusion criteria

Exclusion criteria: 1.Incomplete medical records with missing core variable documentation, including unclear SBT outcomes, more than 50% missing Pmus data, or absent 72-hour post-extubation follow-up information. 2.Special conditions or therapeutic interventions: patients complicated with severe coagulation disorders postoperatively (INR>2.0, platelet count <30×10?/L) receiving emergency blood transfusion; patients whose treatment was interrupted during SBT due to severe arrhythmia (e.g., ventricular fibrillation) or cardiac arrest; patients receiving extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) support. 3.Abnormal monitoring conditions: patients with endotracheal tube size less than 7.0 mm or greater than 8.0 mm, accompanied by ventilator leakage exceeding 30% of tidal volume (clearly documented in medical records); patients with distorted Pmus data caused by monitoring equipment malfunction (e.g., more than 3 equipment alarms recorded during monitoring without subsequent calibration). 4.Duplicated enrollment: patients who received repeated endotracheal intubation and multiple spontaneous breathing trials (SBTs) after the same surgical procedure; only data from the first SBT and corresponding extubation will be included in the study.

Design outcomes

Primary

MeasureTime frame
The area under the ROC curve (AUC) of pre-SBT 1-hour non-invasive peak-Pmus for predicting the success of spontaneous breathing trial.;The area under the ROC curve (AUC) of peak-Pmus during SBT for predicting 72-hour post-extubation failure.;

Secondary

MeasureTime frame
Various ventilation parameters of the spontaneous breathing test (breathing rate, shallow rapid breathing index, transpulmonary driving pressure, P0.1).;Comparison of Pmus parameters with traditional offline indicator predictive performance (AUC);Comparison of peak-Pmus and PTP-Pmus among different surgical subgroups.;Total duration of postoperative mechanical ventilation;

Countries

China

Contacts

Public ContactHong Jiajia

The First Affiliated Hospital,Sun Yat-sen University

1245006773@qq.com+86 20 87332200

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026