Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526598
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Inspiratory Effort-Targeted Pressure Support Ventilation IT-PSV Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IT-PSV
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
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 patients 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 11 to pressure support setting by a PMI-targeted strategy or a traditional VTRR-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 VTRR-targeted group the pressure support is adjusted to obtain a VT between 6 and 8 mlkg predicted body weight and RR between 20 and 35 breathsmin
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
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 11 to pressure support setting by a PMI-targeted strategy or a traditional VTRR-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 VTRR-targeted group the pressure support is adjusted to obtain a VT between 6 and 8 mlkg predicted body weight and RR between 20 and 35 breathsmin
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None