Critical CareIT-PSVNCT06526598
Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial
A study testing PMI-targeted pressure support setting and adjustment and VT/RR-targeted pressure support setting and adjustment in people with Critical Care and Acute Hypoxic Respiratory Failure, run by Capital Medical University at 1 site in China.
Trial summary
The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Acute Hypoxic Respiratory Failure, Ventilator-Induced Lung Injury
- What is being tested?
- PMI-targeted pressure support setting and adjustment and VT/RR-targeted pressure support setting and adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 619 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2026to 28 Feb 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
- PSV initiated during the last 24 hours;
- Mechanical ventilation expected to be required for at least 24-48 h by responsible physicians;
- The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure PEEP);
- No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4.
Who cannot join
- Age younger than 18 years old;
- Initiation of PSV before ICU admission;
- Duration of mechanical ventilation longer than 7 days before enrollment;
- History of neuromuscular diseases;
- Clinical suspicion of increased intracranial pressure;
- Extracorporeal support;
- Moribund conditions;
- Refusal by the ICU physicians or the patient.
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
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Jian-Xin Zhou, MD, 8610 6392 6666, zhoujx.cn@icloud.com
About this study
Official title: A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation
The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation.
The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.
Read the detailed description
Pressure-support ventilation (PSV) is widely used in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. Traditionally, pressure support levels are set according to tidal volume (VT) and respiratory rate (RR). However, previous studies have shown that over-assistance under PSV is not uncommon based on this setting strategy. Pressure muscle index (PMI) is an inspiratory effort monitoring, which can be easily obtained on the ventilator screen at the bedside.
Aim:
The aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional approach, can improve clinical outcomes in adult participants undergoing PSV.
Design:
This is a two-arm cluster randomized trial in 18 clusters randomized 1:1 to pressure support setting by a PMI-targeted strategy or a traditional VT/RR-targeted strategy.
Population:
Patients with acute hypoxic respiratory failure who have been intubated within seven days and undergoing PSV within 24 hours will be enrolled.
Intervention:
During the study, a general standard of care for mechanical ventilation will be followed, including the transition of control modes to PSV, the principle PSV settings (trigger, cycle-off, fraction of inspired oxygen, and positive end-expiratory pressure), rescue backup of controlled ventilation, performance of spontaneous breathing trial, and weaning and extubation.
In the VT/RR-targeted group, the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths/min.
In the PMI-targeted group, the pressure support is adjusted according to the PMI between 0 and 2 cmH2O.
During the study period in the two groups, pressure support adjustment will be performed at least twice daily.
The intervention will be implemented over 24 months.
Training:
After randomization, a four-week comprehensive training program will be conducted for all staff in the participating ICUs before the formal start of the trial.
Outcomes:
The primary outcome is the ventilator free day during 28 days. Secondary outcomes include total duration of mechanical ventilation, the time before the first spontaneous breathing trial, weaning time, frequency of prolonged and failed weaning, frequency of mechanical ventilation longer than 21 days, length of stay in the ICU and hospital, ICU mortality, hospital mortality, and 28-day mortality.
Study sites:
The study will be conducted in 18 ICUs in university-affiliated hospitals in three provinces in China: Beijing, Tianjin, and Hebei.
- Being tested
- PMI-targeted pressure support setting and adjustment, VT/RR-targeted pressure support setting and adjustment
- Keywords
- pressure support ventilation, pressure muscle index, inspiratory effort
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMI-targeted pressure support setting and adjustmentProcedure or surgery
During PSV, the pressure support is set and adjusted to a PMI target between 0 and 2 cmH2O.
VT/RR-targeted pressure support setting and adjustmentProcedure or surgery
During PSV, pressure support is set and adjusted according to a VT/RR target of VT between 6 and 8 ml/kg predicted body weight, RR between 20 and 35 breaths/min, and no signs of respiratory distress.
| Study group | Role | What they receive |
|---|---|---|
| PMI-targeted group | Experimental | The participants will be treated according to the standard of care for mechanical ventilation. During PSV, pressure support is set and adjusted according to the PMI target. Receives: Procedure: PMI-targeted pressure support setting and adjustment |
| VT/RR-targeted group | Active comparator | The participants will be treated according to the standard of care for mechanical ventilation. During PSV, pressure support is set and adjusted according to the VT/RR target. Receives: Procedure: VT/RR-targeted pressure support setting and adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days (VFDs) at day 28 after enrollment.
The primary outcome is the ventilator-free days (VFDs) at day 28 after enrollment. The calculation of VFDs will follow the standard recommendations.
Measured: 28 days
Secondary outcomes (8)
Duration of mechanical ventilation after enrollment
Defined as the time intervals from enrollment to successful weaning. For patients with re-intubation or restoration of mechanical ventilation via tracheostomy within seven days after extubation and discontinuation of ventilation, the thereafter duration will be added.
Measured: 28 days
The time before the first spontaneous breathing trial
Defined as the time interval from intubation and mechanical ventilation to the first spontaneous breathing trial attempt.
Measured: 28 days
Weaning time
Defined as the time from the first SBT attempt to successful discontinuation of mechanical ventilation.
Measured: 28 days
Frequency of prolonged weaning
Prolonged weaning is defined as that weaning is still not terminated 7 days after the first separation attempt.
Measured: 28 days
ICU mortality
Death in the ICU.
Measured: 28 days
Hospital mortality
Death in the hospital.
Measured: 28 days
Length of stay in the ICU
Defined as the time interval from enrollment to discharge from ICU or death.
Measured: 28 days
Length of stay in the hospital
Defined as the time interval from enrollment to discharge from hospital or death.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start19 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 619 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526598
- Sponsor's protocol ID
- IIT2024-029-004
- Acronym
- IT-PSV
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu WY, Miao MY, Gao R, Yang YL, Zhang L, Weng L, Zhu FX, Liu L, Zhou JX. A cluster randomized trial on inspiratory effort-targeted pressure support adjustment strategy in patients undergoing assisted mechanical ventilation: protocol for the IT-PSV study. Front Med (Lausanne). 2024 Nov 8;11:1483976. doi: 10.3389/fmed.2024.1483976. eCollection 2024.
PubMed 39582975
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06526598
- Acronym / sponsor ID
- IT-PSV / IIT2024-029-004
- Keywords
- pressure support ventilation, pressure muscle index, inspiratory effort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 619 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Jul 2024 (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 Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation.
The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.
Detailed description
Pressure-support ventilation (PSV) is widely used in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. Traditionally, pressure support levels are set according to tidal volume (VT) and respiratory rate (RR). However, previous studies have shown that over-assistance under PSV is not uncommon based on this setting strategy. Pressure muscle index (PMI) is an inspiratory effort monitoring, which can be easily obtained on the ventilator screen at the bedside.
Aim:
The aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional approach, can improve clinical outcomes in adult participants undergoing PSV.
Design:
This is a two-arm cluster randomized trial in 18 clusters randomized 1:1 to pressure support setting by a PMI-targeted strategy or a traditional VT/RR-targeted strategy.
Population:
Patients with acute hypoxic respiratory failure who have been intubated within seven days and undergoing PSV within 24 hours will be enrolled.
Intervention:
During the study, a general standard of care for mechanical ventilation will be followed, including the transition of control modes to PSV, the principle PSV settings (trigger, cycle-off, fraction of inspired oxygen, and positive end-expiratory pressure), rescue backup of controlled ventilation, performance of spontaneous breathing trial, and weaning and extubation.
In the VT/RR-targeted group, the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths/min.
In the PMI-targeted group, the pressure support is adjusted according to the PMI between 0 and 2 cmH2O.
During the study period in the two groups, pressure support adjustment will be performed at least twice daily.
The intervention will be implemented over 24 months.
Training:
After randomization, a four-week comprehensive training program will be conducted for all staff in the participating ICUs before the formal start of the trial.
Outcomes:
The primary outcome is the ventilator free day during 28 days. Secondary outcomes include total duration of mechanical ventilation, the time before the first spontaneous breathing trial, weaning time, frequency of prolonged and failed weaning, frequency of mechanical ventilation longer than 21 days, length of stay in the ICU and hospital, ICU mortality, hospital mortality, and 28-day mortality.
Study sites:
The study will be conducted in 18 ICUs in university-affiliated hospitals in three provinces in China: Beijing, Tianjin, and Hebei.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMI-targeted group | Experimental | Procedure: PMI-targeted pressure support setting and adjustmentThe participants will be treated according to the standard of care for mechanical ventilation. During PSV, pressure support is set and adjusted according to the PMI target. |
| VT/RR-targeted group | Active comparator | Procedure: VT/RR-targeted pressure support setting and adjustmentThe participants will be treated according to the standard of care for mechanical ventilation. During PSV, pressure support is set and adjusted according to the VT/RR target. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PSV initiated during the last 24 hours;
- Mechanical ventilation expected to be required for at least 24-48 h by responsible physicians;
- The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure PEEP);
- No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4.
Key exclusion criteria (8 listed)
- Age younger than 18 years old;
- Initiation of PSV before ICU admission;
- Duration of mechanical ventilation longer than 7 days before enrollment;
- History of neuromuscular diseases;
- Clinical suspicion of increased intracranial pressure;
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 |
|---|---|---|
| PMI-targeted pressure support setting and adjustmentDuring PSV, the pressure support is set and adjusted to a PMI target between 0 and 2 cmH2O. | Procedure or surgery | PMI-targeted group |
| VT/RR-targeted pressure support setting and adjustmentDuring PSV, pressure support is set and adjusted according to a VT/RR target of VT between 6 and 8 ml/kg predicted body weight, RR between 20 and 35 breaths/min, and no signs of respiratory distress. | Procedure or surgery | VT/RR-targeted group |
Primary outcome
Ventilator-free days (VFDs) at day 28 after enrollment.
Time frame: 28 days
The primary outcome is the ventilator-free days (VFDs) at day 28 after enrollment. The calculation of VFDs will follow the standard recommendations.
8 secondary outcomes
Duration of mechanical ventilation after enrollment
Time frame: 28 days
The time before the first spontaneous breathing trial
Time frame: 28 days
Weaning time
Time frame: 28 days
Frequency of prolonged weaning
Time frame: 28 days
ICU mortality
Time frame: 28 days
Hospital mortality
Time frame: 28 days
Length of stay in the ICU
Time frame: 28 days
Length of stay in the hospital
Time frame: 28 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 21 Jan 2026.
- Derived from this study: PubMed 39582975Lu WY, Miao MY, Gao R, Yang YL, Zhang L, Weng L, Zhu FX, Liu L, Zhou JX. A cluster randomized trial on inspiratory effort-targeted pressure support adjustment strategy in patients undergoing assisted mechanical ventilation: protocol for the IT-PSV study. Front Med (Lausanne). 2024 Nov 8;11:1483976. doi: 10.3389/fmed.2024.1483976. eCollection 2024.
- 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.
Jian-Xin Zhou, MD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMI-targeted pressure support setting and adjustment and VT/RR-targeted pressure support setting and adjustment in people with Critical Care and Acute Hypoxic Respiratory Failure, 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 4 inclusion and 8 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 21 Jan 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 Jian-Xin Zhou, MD (8610 6392 6666, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days (VFDs) at day 28 after enrollment. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526598, which also lists 1 linked publication.
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 21 Jan 2026.