Patients requiring invasive mechanical ventilation Respiratory
Conditions
Interventions
Current interventions as of 16/01/2026:
Participants are randomly divided using a random number table into the experimental group (PAV+ group) and the control group (PSV group). The participants in
Sponsors
Medtronic (China)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/05/2026: 1. Age =18 years old, <90 years old 2. Patients with mechanical ventilation =48 h 3. Failed SBT (Spontaneous Breathing Trial) mechanical ventilation duration = 48 hours; or successful SBT plus mechanical ventilation duration = 7 days. 4. Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity and other reasons, or the subject is a minor, his guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g. illiterate subjects), the witness is required to witness the informed process and sign the informed consent form _____ Previous inclusion criteria as of 11/09/2025: 1. Age =18 years old 2. Patients with mechanical ventilation =48 h 3. Failed SBT (Spontaneous Breathing Trial) mechanical ventilation duration = 48 hours; or successful SBT plus mechanical ventilation duration = 7 days. 4. Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity and other reasons, or the subject is a minor, his guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g. illiterate subjects), the witness is required to witness the informed process and sign the informed consent form _____ Previous inclusion criteria: 1. Age =18 years old 2. Patients with mechanical ventilation =48 h 3. Patients with mechanical ventilation who meet the first SBT failure (excluding iatrogenic factors) 4. Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity and other reasons, or the subject is a minor, his guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g. illiterate subjects), the witness is required to witness the informed process and sign the informed consent form
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 16/01/2026: 1. Airway/Pleural pathology: Pneumothorax, bronchopleural or bronchotracheal fistula 2. Concomitant neuromuscular disease 3. Severe chronic obstructive pulmonary disease 4. Contraindications to EIT (e.g., chest wall wounds or implanted pacemakers) 5. Other: Advanced malignancy (Stage IV) or withdrawal/discontinuation of treatment before extubation _____ Previous exclusion criteria as of 11/09/2025: 1.Neuromuscular diseases (e.g., myasthenia gravis) 2.Tracheoesophageal fistula, tracheomediastinal fistula, etc. _____ Previous exclusion criteria: 1. Myasthenia gravis and other neuromuscular diseases 2. Tracheoesophageal fistula, tracheomediastinal fistula 3. Patients with high endogenous peep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 16/01/2026: Obtained from the patient's medical records at discharge: 1. Successful weaning rate 2. Ventilator-free days within 28 days 3. Time from enrollment to successful weaning 4. Total duration of mechanical ventilation 5. Total length of hospital stay and ICU length of stay 6. Reintubation rate within 28 days after enrollment _____ Previous primary outcome measure as of 11/09/2025: 1. Before and after randomization, the patients' diaphragmatic function and pulmonary function are evaluated using diaphragmatic ultrasound or Electrical Impedance Tomography (EIT) at regular intervals, respectively. 2. During the weaning period, ventilator parameters and gas exchange indicators are directly monitored via the ventilator data acquisition system on a daily basis, including peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), work of breathing (WOB), fraction of inspired oxygen (FiO2), mechanical power (MP), maximal inspiratory pressure (MIP), rapid shallow breathing index (RSBI), pH value, arterial partial pressure of carbon dioxide (PaCO2), end-tidal partial pressure of carbon dioxide (ETCO2), and PaO2/FiO2 ratio (oxygenation index), etc. 3. After grouping, outcome indicators such as the time of successful extubation are directly recorded according to the actual condition of each patient. _____ Previous primary outcome measure: 1. Diaphragm activity and thickening fraction evaluated by phrenic ultrasound every morning when weaning 2. Ventilator parameters and gas exchange indicators (Peak Inspiratory Pressure [PIP], positive end-expiratory pressure [PEEP], work of breathing [WOB], FiO2, mechanical energy [MP] , maximal inspiratory pressure [MIP], rapid shallow breathing index [RSBI], pH, PaCO2, ETCO2, PaO2/FiO2, etc) directly observed on the ventilator data acquisition system every day when weaning 3. First spontaneous breathing test (SBT) time, first SBT success time and extubation success time directly | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 16/01/2026: Diaphragm function will be assessed using diaphragm ultrasound and electrical impedance tomography (EIT) at two time points, before and after randomization. During the weaning process, ventilator parameters and gas exchange indices will be monitored daily. _____ Previous secondary outcome measures as of 11/09/2025: Obtained from the patient's medical records at discharge: 1. Successful Weaning 2. ICU Length of Stay 3. Time from Enrollment to Successful Weaning 4. Total Duration of Mechanical Ventilation 5. Duration of Mechanical Ventilation within 28 Days of Enrollment 6. Total Hospital Length of Stay 7. Reintubation within 28 Days of Enrollment _____ Previous secondary outcome measures: Obtained from the patient's medical records at discharge: 1. No ventilator-free day (VFD) within 28 days 2. Length of stay in ICU 3. ICU mortality 4. Hospitalization mortality 5. Complications after extubation 6. Success rate and time of 28-day machine removal | — |
Countries
China
Contacts
Public ContactHuiqing;Siyu Ge;Zhang
;
Outcome results
None listed