An interventional study of Pressure support ventilation protocol and Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV) in Airway Occlusion Pressure, Pressure Support Ventilation and Conventional Management, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Patients will receive a conventional pressure support ventilation protocol.
Other: Pressure support ventilation protocol
Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).
Other: Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)
Patients will receive a conventional pressure support ventilation protocol.
Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).
Ventilator-Free Days
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: Day 28 after the procedure
Duration of Mechanical Ventilation
Duration of Mechanical Ventilation (DMV) is defined as the total days on mechanical ventilation (MV) from randomization until final successful extubation.
Time frame: Till final successful extubation (Up to 48 hours)
Length of stay in the intensive care unit
The length of stay in the intensive care unit (ICU) will be recorded from ICU admission to ICU discharge.
Time frame: Till the discharge from intensive care unit (Up to 28 days)
Patient-Ventilator Asynchrony Index (PVAI)
Daily analysis of a 10-minute waveform segment. "PVAI"="Asynchronous events" /"Total breaths" ×100
Time frame: Day 28 after the procedure
Dexmedetomidine requirement
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: Day 28 after the procedure
Failed weaning
"Failed weaning" is defined as reintubation within 48 hours after extubation.
Time frame: 48 hours after extubation
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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