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NCT Number: NCT07709182

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Al Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Aliaa M Belal, MD

SUB_INVESTIGATOR

Ghada F Elbaradey, MD

SUB_INVESTIGATOR

Muhammad A Kandil, MSc

CONTACT

[email protected]

00201022644722

Sohair M Soliman, MD

SUB_INVESTIGATOR

Taysser M Abdalraheem, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pressure support ventilation protocol

Other

Patients will receive a conventional pressure support ventilation protocol.

Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)

Other

Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV).

Primary outcomes

  1. Ventilator-Free Days

    Time frame: 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 outcomes

  1. Duration of Mechanical Ventilation

    Time frame: 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.

  2. Length of stay in the intensive care unit

    Time frame: 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.

  3. Patient-Ventilator Asynchrony Index (PVAI)

    Time frame: Day 28 after the procedure

    Daily analysis of a 10-minute waveform segment. "PVAI"="Asynchronous events" /"Total breaths" ×100

  4. Dexmedetomidine requirement

    Time frame: 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.

  5. Failed weaning

    Time frame: 48 hours after extubation

    "Failed weaning" is defined as reintubation within 48 hours after extubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad A Kandil, MSc

CONTACT

[email protected]

00201022644722

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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