Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pressure support ventilation protocol, Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).
- Who it may be relevant to
- Registry conditions: Airway Occlusion Pressure, Pressure Support Ventilation, Conventional Management, Weaning Window Patients. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial
Overview
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
- Other Pressure support ventilation protocol
Patients will receive a conventional pressure support ventilation protocol. - Other Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)
Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).
Primary outcome measures
- Ventilator-Free Days [Time frame: Day 28 after the procedure]
Secondary outcome measures (5)
- Duration of Mechanical Ventilation [Time frame: Till final successful extubation (Up to 48 hours)]
- Length of stay in the intensive care unit [Time frame: Till the discharge from intensive care unit (Up to 28 days)]
- Patient-Ventilator Asynchrony Index (PVAI) [Time frame: Day 28 after the procedure]
- Dexmedetomidine requirement [Time frame: Day 28 after the procedure]
- Failed weaning [Time frame: 48 hours after extubation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07709182 · 36265MD41027/1/6