Titration of PS Guided by FI : A Pilot Study

NCT07769307 | Not Yet Recruiting

• 1 other identifier: KY-2025-336-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  During the intervention period

Secondary Outcomes (10)

• Emergency termination rate

  Through study completion, up to 28 days

• Safety assessment failure rate

  During the intervention period

• Incidence of adverse events

  Through study completion, up to 28 days

• Duration of invasive mechanical ventilation

  Through study completion, up to 28 days

• Extubation failure rate

  Through study completion, up to 28 days

Study Arms (2)

Flow index-guided PS titration

EXPERIMENTAL

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

Conventional PS titration

ACTIVE COMPARATOR

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

Interventions

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.

Flow index-guided PS titration

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.

Conventional PS titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical University Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Central Study Contacts

Yi-Min Zhou

CONTACT

+8618518474093; acapoftea2021@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)