NCT06526598

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 619 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Critical Care
• Acute Hypoxic Respiratory Failure
• Ventilator-Induced Lung Injury

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-01-19
• Primary completion: 2027-01-31
• Completion: 2027-02-28
• First posted: 2024-07-30
• Last updated: 2026-01-21

Locations

1 site across 1 country: China