Early Warning and Stratified Diagnosis of Postoperative Respiratory Failure Based on Ventilator Waveform Image Features

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorWest China Hospital

About this trial

I. Study Background Postoperative respiratory failure (PRF) is a common and serious complication following major surgery, significantly increasing the rates of ICU admission and mortality. Traditional early warning methods primarily rely on blood gas analysis and vital sign monitoring, which are often delayed and may fail to identify early pathological changes in a timely manner. In recent years, ventilator waveforms, as dynamic information that directly reflects respiratory mechanics and airway conditions, have gradually attracted increasing attention in the optimization of respiratory support. International studies have suggested that analysis of ventilator waveform features may help identify patient-ventilator asynchrony, excessive spontaneous respiratory effort, ventilation-perfusion mismatch, and ventilator-related complications. In China, although a limited number of studies have explored this area, most have focused on individual parameters and lack systematic and prospective clinical validation. Therefore, this study aims to establish a large prospective cohort and integrate image feature extraction with stratified diagnostic modeling to achieve early warning and risk stratification of postoperative respiratory failure. This study is expected not only to address the current gap in this field in China but also to provide evidence-based support for precision respiratory management and improved clinical outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years;

Patients receiving mechanical ventilation after surgery and transferred directly to the ICU;

Patients expected to require or actually requiring mechanical ventilation for more than 24 hours after surgery;

Patients or their legally authorized representatives providing written informed consent.

Disqualifiers

Respiratory failure occurring before surgery;

Severe pulmonary disease diagnosed before surgery, including but not limited to severe chronic obstructive pulmonary disease (COPD; GOLD stage 3-4), severe interstitial lung disease (PaO₂/FiO₂ <300 mmHg), active pneumonia, and severe pulmonary hypertension;

Preoperative mechanical ventilation for >48 hours;

A decision made immediately after surgery to withhold or withdraw active treatment, including invasive mechanical ventilation;

Trial population

The study population will consist of patients receiving mechanical ventilation who are transferred to the ICU after surgery at our hospital. To ensure adequate representation of different surgical types and disease severity levels and to facilitate subsequent stratified analyses, stratified consecutive enrollment will be adopted.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: PRF Group
Group B: Non-PRF Group

Trial outcomes

Primary outcomes

1

Occurrence of postoperative respiratory failure (PRF)

Patients who require postoperative mechanical ventilation for more than 48 hours or undergo unplanned reintubation within 30 days.

Time frame
30 days after surgery

Secondary outcomes

1

Time from surgery to the occurrence of PRF

Time from surgery to the occurrence of PRF

Time frame
30 days after surgery
2

Total duration of mechanical ventilation

Total duration of mechanical ventilation

Time frame
30 days after surgery
3

Extubation failure

Reintubation within 48 hours after extubation

Time frame
30 days after surgery
4

Postoperative pulmonary complications

Atelectasis, pneumonia, respiratory infection, pleural effusion, pneumothorax, respiratory failure, acute respiratory distress syndrome (ARDS), pulmonary edema, and other relevant complications

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

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