P0.1-guided pressure support ventilation during weaning from mechanical ventilation
Official title: Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial
Run by Tanta University · NCT07709182 · Data updated 2026-11-12
This study tests whether using airway occlusion pressure (P0.1) to guide pressure support ventilation helps adults on the weaning path from mechanical ventilation more effectively than conventional management.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Al Gharbia) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07709182 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults ≥21 years on pressure support ventilation for at least 24 hours in the weaning window with MAP ≥60 mmHg and RASS -1 to 0.
✕Probably not a fit
Patients with neuromuscular disorders affecting respiratory drive, deep sedation, high vasopressor needs, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial investigates whether a P0.1-guided PSV strategy can improve weaning outcomes compared with conventional management in adults on the weaning window. Mechanically ventilated patients meeting criteria will receive PSV titrated by P0.1 measurements to align ventilatory support with respiratory drive, potentially reducing weaning time and complications. The study notes that traditional titration relies on clinical assessment and may miss asynchronies, whereas P0.1 offers a direct read on patient drive. Eligible participants are adults ≥21 years, in the weaning window with improving respiratory status, stable hemodynamics, and light sedation. Exclusions include neuromuscular disorders, high sedation depth, spinal injuries, pregnancy, and other instability factors.
Why it matters
Potential benefit: If successful, patients may experience shorter weaning periods and fewer ventilation-associated complications through more accurate tailoring of support to their respiratory drive.
How similar studies have gone: Some prior work suggests that objective measures of respiratory drive can improve synchrony and weaning decisions, but this exact P0.1-guided approach is relatively novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tanta University
Tanta, Al Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Muhammad A Kandil, MSc
- Email: muhammad.kandil@med.tanta.edu.eg
- Phone: 00201022644722
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.