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Clinical Trials in China / NCT06526598
Recruiting Not applicable

Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial

NCT06526598 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2026-01-19
Last updated
2026-01-21

Condition(s) studied

Critical CareAcute Hypoxic Respiratory FailureVentilator-Induced Lung Injury

Investigational drug(s) / intervention(s)

PMI-targeted pressure support setting and adjustmentVT/RR-targeted pressure support setting and adjustment

PMI-targeted pressure support setting and adjustment: 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 adjustment: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Mechanically ventilated patients, who are admitted to the ICU with acute hypoxic respiratory failure, will be consecutively screened daily at 08:00-10:00 morning rounds. Inclusion criteria: 1. PSV initiated during the last 24 hours; 2. Mechanical ventilation expected to be required for at least 24-48 h by responsible physicians; 3. 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); 4. 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. Exclusion criteria included: 1. Age younger than 18 years old; 2. Initiation of PSV before ICU admission; 3. Duration of mechanical ventilation longer than 7 days before enrollment; 4. History of neuromuscular diseases; 5. Clinical suspicion of increased intracranial pressure; 6. Extracorporeal support; 7. Moribund conditions; 8. Refusal by the ICU physicians or the patient.

Primary outcome measure(s)

  • Ventilator-free days (VFDs) at day 28 after enrollment. — 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.

Trial sites (1)

FacilityCityRegionStatus
Beijing Shijitan Hospital Beijing Beijing Municipality Recruiting

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Other trials for the same condition

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments Recruiting
Electrical Impedance Tomography-Based Prognostic Model for ARDS Recruiting
Mechanism Study of Ventilator-Induced Lung Injury in Elderly People. Recruiting
A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial Recruiting
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06526598 on ClinicalTrials.gov ↗ ← All trials in China