Titration of PS Guided by FI : A Pilot Study

NCT07769307 — Not applicable, Not yet recruiting, 60 participants, Capital Medical University

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Titration of Pressure Support Guided by Flow Index: A Pilot Study

Registry	NCT07769307
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	Capital Medical University (Other)
Conditions	Mechanical Ventilation
Interventions	FI-guided ventilator support adjustment, Conventional PS titration (Procedure)
Dates	start 2026-09-01 (estimated), primary completion 2027-02-28 (estimated), completion 2027-04-30 (estimated), first posted 2026-08-17, last updated 2026-08-17
Locations	1 site in China

-Summary

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:

* Is FI-guided PS titration feasible and safe in a clinical ICU setting, as assessed by the proportion of failed safety assessments and the emergency termination rate?
* Does FI-guided PS titration result in a greater proportion of data collection points with respiratory muscle pressure (Pmus) within the normal range (5-10 cmH₂O) compared to conventional PS titration based on tidal volume and respiratory rate? Researchers will compare the FI-guided PS titration group to the conventional PS titration group to see if FI-guided adjustment improves the proportion of assessments with adequate inspiratory effort (avoiding both excessive and insufficient support), and whether it leads to differences in clinical outcomes including duration of mechanical ventilation, extubation failure rate, tracheostomy rate, length of ICU and hospital stay, and in-hospital all-cause mortality.

Participants will:

* Be randomly assigned in a 1:1 ratio to receive either conventional PS titration (adjusting PS to achieve tidal volume of 6-8 mL/kg predicted body weight and respiratory rate of 20-30 breaths/min) or FI-guided PS titration (adjusting PS to maintain FI between 2.6 and 4.5)
* Complete an intervention period with PS adjustments performed twice daily (at 8:00 AM and 8:00 PM) according to the assigned protocol
* Have Pmus assessed at each data collection point to determine whether inspiratory effort falls within the target range
* Undergo a 2-minute safety assessment after each PS adjustment to ensure adequate ventilation and avoid excessive airway pressures or respiratory distress
* Be followed for up to 28 days after enrollment or until ICU discharge, with extended follow-up to hospital discharge or death for clinical outcome evaluation

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+Arms and interventions

Arm	Type	Interventions	Description
Flow index-guided PS titration	Experimental	Procedure: FI-guided ventilator support adjustment	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.
Conventional PS titration	Active comparator	Procedure: Conventional PS titration	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.

FI-guided ventilator support adjustment (Procedure): 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.
Conventional PS titration (Procedure): 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.

+Outcome measures

Primary outcomes

Proportion of assessments with Pmus in target range [During the intervention period]: 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.

Secondary outcomes

Emergency termination rate [Through study completion, up to 28 days]: 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.
Safety assessment failure rate [During the intervention period]: Proportion of safety assessments that failed to meet predefined criteria after PS adjustment.
Incidence of adverse events [Through study completion, up to 28 days]: Occurrence of hypoxemia, respiratory distress, or barotrauma during the study period, recorded by type, timing, and relationship to the intervention.
Duration of invasive mechanical ventilation [Through study completion, up to 28 days]: Time from enrollment to successful extubation, measured in days.
Extubation failure rate [Through study completion, up to 28 days]: Proportion of participants who fail extubation and require reintubation within 48 hours after planned extubation.
Tracheostomy rate [Through study completion, up to 28 days]: Proportion of participants who undergo tracheostomy during the study period.
Length of ICU stay [Through study completion, up to 28 days]: Total duration of ICU admission from enrollment to ICU discharge or death, measured in days.
Length of hospital stay [Through study completion, up to 90 days]: Total duration of hospital admission from enrollment to hospital discharge or death, measured in days.
In-hospital all-cause mortality [Through study completion, up to 90 days]: Proportion of participants who die during the index hospitalization from any cause.
Total hospitalization cost [From enrollment to hospital discharge or death, up to 90 days]: Total direct medical costs incurred during the index hospitalization, including ICU costs, mechanical ventilation-related expenses, medications, procedures, and diagnostic tests.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult patients (age ≥ 18 years) receiving pressure support ventilation (PSV)
* Expected duration of invasive mechanical ventilation > 48 hours

Exclusion Criteria:

* Patients who have received PSV for > 48 hours at the time of screening
* Neuromuscular disease, diaphragmatic dysfunction, or central nervous system disease affecting the respiratory center
* Incomplete lung or chest wall integrity (e.g., pneumothorax, tracheoesophageal fistula, rib fractures)
* Acute respiratory distress syndrome (ARDS) or chronic obstructive pulmonary disease (COPD)
* Body mass index (BMI) > 35 kg/m²
* Pregnancy or lactation
* Participation in another interventional study or refusal to participate

+Locations (1)

Facility	City	Country	Status
Capital Medical University Beijing Tiantan Hospital	Beijing, Beijing Municipality	China