Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients

Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Occlusion Pressure; Pressure Support Ventilation; Conventional Management; Weaning Window Patients
• Intervention / Treatment: Other: Pressure support ventilation protocol; Other: Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad A Kandil, MSc; Phone Number: 00201022644722; Email: muhammad.kandil@med.tanta.edu.eg

Study Locations

• Egypt
  • Al Gharbia
    • Tanta, Al Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Aliaa M Belal, MD
      • Sub-Investigator: Taysser M Abdalraheem, MD
      • Sub-Investigator: Sohair M Soliman, MD
      • Contact: Muhammad A Kandil, MSc; Phone Number: 00201022644722; Email: muhammad.kandil@med.tanta.edu.eg
      • Sub-Investigator: Ghada F Elbaradey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (Control Group); Patients will receive a conventional pressure support ventilation protocol.	Other: Pressure support ventilation protocol; Patients will receive a conventional pressure support ventilation protocol.
Experimental: Group II (Study Group); 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 airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28 after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	Day 28 after the procedure
Failed weaning	"Failed weaning" is defined as reintubation within 48 hours after extubation.	48 hours after extubation

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 36265MD41027/1/6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No