Mechanical VentilationNCT07769307
Titration of PS Guided by FI : A Pilot Study
A study testing FI-guided ventilator support adjustment and Conventional PS titration in people with Mechanical Ventilation, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- FI-guided ventilator support adjustment and Conventional PS titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years) receiving pressure support ventilation (PSV)
- Expected duration of invasive mechanical ventilation > 48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
About this study
Official title: Titration of Pressure Support Guided by Flow Index: 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:
Read more
- 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
- Being tested
- FI-guided ventilator support adjustment, Conventional PS titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FI-guided ventilator support adjustmentProcedure or surgery
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 titrationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional PS titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intervention period
Secondary outcomes (10)
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.
Measured: Through study completion, up to 28 days
Safety assessment failure rate
Proportion of safety assessments that failed to meet predefined criteria after PS adjustment.
Measured: 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.
Measured: Through study completion, up to 28 days
Duration of invasive mechanical ventilation
Time from enrollment to successful extubation, measured in days.
Measured: 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.
Measured: Through study completion, up to 28 days
Tracheostomy rate
Proportion of participants who undergo tracheostomy during the study period.
Measured: 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.
Measured: 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.
Measured: Through study completion, up to 90 days
In-hospital all-cause mortality
Proportion of participants who die during the index hospitalization from any cause.
Measured: 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.
Measured: From enrollment to hospital discharge or death, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yi-Min, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769307
- Sponsor's protocol ID
- KY-2025-336-02
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration of Pressure Support Guided by Flow Index: A Pilot Study
- ClinicalTrials.gov ID
- NCT07769307
- Acronym / sponsor ID
- KY-2025-336-02
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow index-guided PS titration | Experimental | Procedure: FI-guided ventilator support adjustmentPatients 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 titrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 years) receiving pressure support ventilation (PSV)
- Expected duration of invasive mechanical ventilation > 48 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FI-guided ventilator support adjustmentFlow 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. | Procedure or surgery | Flow index-guided PS titration |
| Conventional PS titrationPatients 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 or surgery | Conventional PS titration |
Primary outcome
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.
10 secondary outcomes
Emergency termination rate
Time frame: Through study completion, up to 28 days
Safety assessment failure rate
Time frame: During the intervention period
Incidence of adverse events
Time frame: Through study completion, up to 28 days
Duration of invasive mechanical ventilation
Time frame: Through study completion, up to 28 days
Extubation failure rate
Time frame: Through study completion, up to 28 days
Tracheostomy rate
Time frame: Through study completion, up to 28 days
Length of ICU stay
Time frame: Through study completion, up to 28 days
Length of hospital stay
Time frame: Through study completion, up to 90 days
In-hospital all-cause mortality
Time frame: Through study completion, up to 90 days
Total hospitalization cost
Time frame: From enrollment to hospital discharge or death, up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FI-guided ventilator support adjustment and Conventional PS titration in people with Mechanical Ventilation, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Min Zhou (+8618518474093, acapoftea2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of assessments with Pmus in target range (time frame: During the intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.