Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07769307

Titration of PS Guided by FI : A Pilot Study

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of assessments with Pmus in target range

    Time frame: 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

  1. Emergency termination rate

    Time frame: 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.

  2. Safety assessment failure rate

    Time frame: During the intervention period

    Proportion of safety assessments that failed to meet predefined criteria after PS adjustment.

  3. Incidence of adverse events

    Time frame: 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.

  4. Duration of invasive mechanical ventilation

    Time frame: Through study completion, up to 28 days

    Time from enrollment to successful extubation, measured in days.

  5. Extubation failure rate

    Time frame: Through study completion, up to 28 days

    Proportion of participants who fail extubation and require reintubation within 48 hours after planned extubation.

  6. Tracheostomy rate

    Time frame: Through study completion, up to 28 days

    Proportion of participants who undergo tracheostomy during the study period.

  7. Length of ICU stay

    Time frame: Through study completion, up to 28 days

    Total duration of ICU admission from enrollment to ICU discharge or death, measured in days.

  8. Length of hospital stay

    Time frame: Through study completion, up to 90 days

    Total duration of hospital admission from enrollment to hospital discharge or death, measured in days.

  9. In-hospital all-cause mortality

    Time frame: Through study completion, up to 90 days

    Proportion of participants who die during the index hospitalization from any cause.

  10. Total hospitalization cost

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Min Zhou

CONTACT

[email protected]

+8618518474093

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.