Trial of Inspiratory Effort-Targeted Pressure Support vs Traditional Settings in Adults on Mechanical Ventilation
Led by Capital Medical University · Updated on 2026-01-21
619
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
The trial investigates whether an inspiratory effort-targeted pressure support ventilation IT-PSV strategy can improve clinical outcomes compared to the traditional tidal volume and respiratory rate target in adults undergoing pressure support ventilation. This cluster randomized controlled trial focuses on patients with acute hypoxic respiratory failure who have been intubated within seven days and are receiving PSV within 24 hours. The study aims to explore a physiological-oriented ventilation management approach that may impact future mechanical ventilation practices.
Participants are randomly assigned to one of two groups one where pressure support is adjusted to target a pressure muscle index PMI between 0 and 2 cmH2O, and another where pressure support is set to achieve a tidal volume between 6 and 8 mlkg predicted body weight and a respiratory rate between 20 and 35 breaths per minute. Adjustments to pressure support occur at least twice daily during the 24-month intervention period. A four-week training program for ICU staff precedes the trial start.
During the study, participants will receive standard mechanical ventilation care including spontaneous breathing trials, weaning, and extubation. Researchers will monitor clinical outcomes such as ventilator-free days within 28 days, duration of mechanical ventilation, time to first spontaneous breathing trial, weaning time, mortality rates, and length of ICU and hospital stays. The study will be conducted in 18 ICUs across several hospitals, with data collected throughout the intervention period.
CONDITIONS
Brief Title
Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial
Research Team
J
Jian-Xin Zhou, MD
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Mechanical ventilation expected to be required for at least 24-48 hours
PaO2/FiO2 ratio less than or equal to 300 mmHg
No sedation or stable sedation with RASS between -2 and +1 or SAS between 3 and 4
You will not qualify if you...
Age younger than 18 years
PSV started before ICU admission
Mechanical ventilation duration longer than 7 days before enrollment
History of neuromuscular diseases
Clinical suspicion of increased intracranial pressure
Receiving extracorporeal support
Moribund condition
Refusal by ICU physicians or patient
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 28 days or until discontinuation of mechanical ventilation
Participants undergo pressure support ventilation with pressure support adjusted either to a pressure muscle index (PMI) target or traditional tidal volume and respiratory rate targets. Pressure support adjustments occur at least twice daily during the mechanical ventilation period.
Multiple visits with pressure support adjustment at least twice daily
Follow-up
Duration - Up to 28 days post enrollment
Participants are monitored for ventilator-free days, weaning outcomes, and length of stay in the ICU and hospital up to 28 days after enrollment.
Follow-up assessments during hospital stay up to 28 days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A cluster randomized trial on inspiratory effort-targeted pressure support adjustment strategy in patients undergoing assisted mechanical ventilation: protocol for the IT-PSV study.