Airway Occlusion Pressure, Conventional Management, Pressure Support Ventilation, Weaning Window Patients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERPressure support ventilation protocol
Patients will receive a conventional pressure support ventilation protocol.
OTHERAirway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)
Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mechanically ventilated adult patients ≥ 21 years. * Patients on pressure support ventilation for at least 24 hours and clinically determined to be in the weaning window (transition between assisted ventilation and spontaneous ventilation) with improving respiratory status. * Hemodynamically stable \[mean arterial pressure (MAP) ≥60 mmHg\]. * All patients will be required to have light sedation with a Richmond Agitation-Sedation Scale (RASS) score between -1 and 0 to allow reliable assessment of respiratory drive.
Exclusion criteria
* Patients with neuromuscular disorders affecting respiratory drive * Glasgow Coma Scale (GCS) score below 8 * Cervical spinal cord injury * Receipt of neuromuscular blockers within the previous 24 hours * Morbid obesity resulting in unreliable respiratory mechanics * Pregnancy * Deep sedation defined as RASS ≤ -2 * Hemodynamic instability requiring escalating vasopressor support.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-Free Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | 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. |
| Length of stay in the intensive care unit | 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. |
| Patient-Ventilator Asynchrony Index (PVAI) | Day 28 after the procedure | Daily analysis of a 10-minute waveform segment. "PVAI"="Asynchronous events" /"Total breaths" ×100 |
| Dexmedetomidine requirement | 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. |
| Failed weaning | 48 hours after extubation | "Failed weaning" is defined as reintubation within 48 hours after extubation. |
Countries
Egypt
Contacts
CONTACTMuhammad A Kandil, MSc
Outcome results
None listed