Tanta University
Tanta, Al Gharbia, 31527, Egypt
Location status: Recruiting
NCT Number: NCT07709182
This study aims to determine whether Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation is superior to conventional management for patients in weaning windows.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Tanta, Al Gharbia, 31527, Egypt
Location status: Recruiting
Mechanical ventilation is an essential modality for critically ill patients with acute respiratory failure. It supports gas exchange and reduces respiratory muscle workload, but prolonged use increases the risk of lung injury, diaphragm dysfunction, and infection. Therefore, the process of ventilator weaning is crucial in optimizing patient outcomes.
Airway occlusion pressure (P0.1), the negative pressure generated 100 ms after the onset of inspiration during an occluded breath, provides a direct measurement of patient respiratory drive independent of lung mechanics. It is a strong indicator of ventilatory demand and drive-load imbalance.
Pressure Support Ventilation (PSV) is commonly used during the weaning window, but conventional titration methods rely on clinical assessment alone. These methods do not reliably identify asynchronous events such as ineffective effort, double triggering, or premature cycling, which prolong ventilation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive a conventional pressure support ventilation protocol.
Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).
Time frame: Day 28 after the procedure
Ventilator-Free Days (VFD) at Day 28, defined as the number of days a patient is free from mechanical ventilation within the first 28 days after randomization. VFD are calculated as 28 minus the total days on mechanical ventilation from Day 0 until successful extubation.
Time frame: Till final successful extubation (Up to 48 hours)
Duration of Mechanical Ventilation (DMV) is defined as the total days on mechanical ventilation (MV) from randomization until final successful extubation.
Time frame: Till the discharge from intensive care unit (Up to 28 days)
The length of stay in the intensive care unit (ICU) will be recorded from ICU admission to ICU discharge.
Time frame: Day 28 after the procedure
Daily analysis of a 10-minute waveform segment. "PVAI"="Asynchronous events" /"Total breaths" ×100
Time frame: Day 28 after the procedure
Total dose of dexmedetomidine administered to maintain the target sedation level of Richmond Agitation-Sedation Scale (RASS) -1 to 0 during the weaning period.
Time frame: 48 hours after extubation
"Failed weaning" is defined as reintubation within 48 hours after extubation.
Interested in participating?
Request InfoTanta University
Other
Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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