RecruitingNot ApplicableNCT06526598

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

A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation

Sponsor

Capital Medical University

Enrollment

619 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Critical Care Acute Hypoxic Respiratory Failure

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

Min Age: 18 Years

Inclusion Criteria5

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.
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.

Exclusion Criteria8

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.

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Interventions

PROCEDUREPMI-targeted pressure support setting and adjustment

During PSV, the pressure support is set and adjusted to a PMI target between 0 and 2 cmH2O.

PROCEDUREVT/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.