An interventional study of FI-guided ventilator support adjustment and Conventional PS titration in Mechanical Ventilation, sponsored by Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
The goal of this single-center, pilot, randomized controlled trial is to evaluate the feasibility and preliminary efficacy of using the Flow Index (FI) to guide Pressure Support (PS) titration in adult patients receiving Pressure Support Ventilation (PSV) who are expected to require invasive mechanical ventilation for more than 48 hours.
The main questions it aims to answer are:
Participants will:
Capital Medical University is the lead sponsor of 295 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive pressure support ventilation (PSV) with PS titration guided by the Flow Index (FI). FI is measured non-invasively from the ventilator flow waveform at the Y-piece using 10 consecutive stable breaths. PS is adjusted to maintain FI within 2.6-4.5: PS is reduced by 2 cmH₂O if FI \< 2.6, or increased by 2 cmH₂O if FI \> 4.5. After each adjustment, a 2-minute safety assessment verifies adequate ventilation (tidal volume ≥4 mL/kg predicted body weight, respiratory rate ≤35 breaths/min, peak inspiratory pressure ≤40 cmH₂O). PS titration is performed twice daily (8:00 AM and 8:00 PM) during the intervention period. All other ventilator settings follow standard care.
Procedure: FI-guided ventilator support adjustment
Patients receive PSV with PS titration based on tidal volume (VT) and respiratory rate (RR). PS is adjusted to achieve VT of 6-8 mL/kg predicted body weight and RR of 20-30 breaths/min: PS is reduced by 2 cmH₂O if VT \> 8 mL/kg and/or RR \< 20 breaths/min, or increased by 2 cmH₂O if VT \< 6 mL/kg and/or RR \> 30 breaths/min. If VT is within 6-8 mL/kg, PS is not adjusted and sedation/analgesia is optimized to achieve target RR. PS titration is performed twice daily (8:00 AM and 8:00 PM) during the intervention period.
Procedure: Conventional PS titration
Flow index (FI)-guided pressure support (PS) titration. FI is measured non-invasively from the ventilator flow waveform at the Y-piece using 10 consecutive stable breaths. PS is adjusted to maintain FI within 2.6-4.5: PS is reduced by 2 cmH₂O if FI \< 2.6, or increased by 2 cmH₂O if FI \> 4.5. After each adjustment, a 2-minute safety assessment verifies adequate ventilation (tidal volume 4-10 mL/kg predicted body weight, respiratory rate ≤35 breaths/min, peak inspiratory pressure ≤40 cmH₂O). PS titration is performed twice daily (8:00 AM and 8:00 PM) during the intervention period. All other ventilator settings follow standard care.
Patients receive PSV with PS titration based on tidal volume (VT) and respiratory rate (RR). PS is adjusted to achieve VT of 6-8 mL/kg predicted body weight and RR of 20-30 breaths/min: PS is reduced by 2 cmH₂O if VT \> 8 mL/kg and/or RR \< 20 breaths/min, or increased by 2 cmH₂O if VT \< 6 mL/kg and/or RR \> 30 breaths/min. If VT is within 6-8 mL/kg, PS is not adjusted and sedation/analgesia is optimized to achieve target RR. PS titration is performed twice daily (8:00 AM and 8:00 PM) during the intervention period.
Proportion of assessments with Pmus in target range
The proportion of data collection points during the intervention period where respiratory muscle pressure (Pmus) falls within the predefined normal range of 5-10 cmH₂O, indicating adequate inspiratory effort.
Time frame: During the intervention period
Emergency termination rate
Proportion of participants requiring emergency termination of the intervention due to severe respiratory distress (SpO₂ \<90%), refractory arrhythmia or hypotension, disease progression requiring deep sedation, or frequent apnea alarms.
Time frame: Through study completion, up to 28 days
Safety assessment failure rate
Proportion of safety assessments that failed to meet predefined criteria after PS adjustment.
Time frame: During the intervention period
Incidence of adverse events
Occurrence of hypoxemia, respiratory distress, or barotrauma during the study period, recorded by type, timing, and relationship to the intervention.
Time frame: Through study completion, up to 28 days
Duration of invasive mechanical ventilation
Time from enrollment to successful extubation, measured in days.
Time frame: Through study completion, up to 28 days
Extubation failure rate
Proportion of participants who fail extubation and require reintubation within 48 hours after planned extubation.
Time frame: Through study completion, up to 28 days
Tracheostomy rate
Proportion of participants who undergo tracheostomy during the study period.
Time frame: Through study completion, up to 28 days
Length of ICU stay
Total duration of ICU admission from enrollment to ICU discharge or death, measured in days.
Time frame: Through study completion, up to 28 days
Length of hospital stay
Total duration of hospital admission from enrollment to hospital discharge or death, measured in days.
Time frame: Through study completion, up to 90 days
In-hospital all-cause mortality
Proportion of participants who die during the index hospitalization from any cause.
Time frame: Through study completion, up to 90 days
Total hospitalization cost
Total direct medical costs incurred during the index hospitalization, including ICU costs, mechanical ventilation-related expenses, medications, procedures, and diagnostic tests.
Time frame: From enrollment to hospital discharge or death, up to 90 days
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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