Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial
- Conditions
- Critical CareAcute Hypoxic Respiratory FailureVentilator-Induced Lung Injury
- Interventions
- Procedure: PMI-targeted pressure support setting and adjustmentProcedure: VT/RR-targeted pressure support setting and adjustment
- Registration Number
- NCT06526598
- Lead Sponsor
- Capital Medical University
- Brief 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 16 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 total duration of mechanical ventilation. Secondary outcomes include 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 16 ICUs in university-affiliated hospitals in three provinces in China: Beijing, Tianjin, and Hebei.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 640
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PMI-targeted group PMI-targeted pressure support setting and adjustment 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. VT/RR-targeted group VT/RR-targeted pressure support setting and adjustment 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.
- Primary Outcome Measures
Name Time Method Total duration of mechanical ventilation 28 days Defined as the time intervals from intubation and mechanical ventilation 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.
- Secondary Outcome Measures
Name Time Method ICU mortality 28 days Death in the ICU.
Weaning time 28 days Defined as the time from the first SBT attempt to successful discontinuation of mechanical ventilation.
Length of stay in the hospital 28 days Defined as the time interval from enrollment to discharge from hospital or death.
Duration of mechanical ventilation after enrollment 28 days 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.
The time before the first spontaneous breathing trial 28 days Defined as the time interval from intubation and mechanical ventilation to the first spontaneous breathing trial attempt.
Frequency of prolonged weaning 28 days Prolonged weaning is defined as that weaning is still not terminated 7 days after the first separation attempt.
Hospital mortality 28 days Death in the hospital.
Length of stay in the ICU 28 days Defined as the time interval from enrollment to discharge from ICU or death.
Trial Locations
- Locations (1)
Beijing Shijitan Hospital
🇨🇳Beijing, Beijing, China