Airway Occlusion PressureNCT07709182
Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients
A study testing Pressure support ventilation protocol and Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV) in people with Airway Occlusion Pressure and Pressure Support Ventilation, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Airway Occlusion Pressure, Pressure Support Ventilation, Conventional Management
- What is being tested?
- Pressure support ventilation protocol and Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, Al Gharbia, 31527
Muhammad A Kandil, MSc, 00201022644722, muhammad.kandil@med.tanta.edu.eg
Sohair M Soliman, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Occlusion Pressure, Pressure Support Ventilation, Conventional Management, Weaning Window Patients
- Being tested
- Pressure support ventilation protocol, Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure support ventilation protocolOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control Group) | Active comparator | Patients will receive a conventional pressure support ventilation protocol. Receives: Other: Pressure support ventilation protocol |
| Group II (Study Group) | Experimental | Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV). Receives: Other: Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28 after the procedure
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 28 after the procedure
Failed weaning
"Failed weaning" is defined as reintubation within 48 hours after extubation.
Measured: 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Feb 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Occlusion PressureStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ahmed Kandil, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709182
- Sponsor's protocol ID
- 36265MD41027/1/6
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07709182
- Acronym / sponsor ID
- 36265MD41027/1/6
- Conditions
- Airway Occlusion Pressure, Pressure Support Ventilation, Conventional Management, Weaning Window Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Control Group) | Active comparator | Other: Pressure support ventilation protocolPatients will receive a conventional pressure support ventilation protocol. |
| Group II (Study Group) | Experimental | Other: Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure support ventilation protocolPatients will receive a conventional pressure support ventilation protocol. | Other | Group I (Control Group) |
| Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)Patients will receive airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV). | Other | Group II (Study Group) |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure support ventilation protocol and Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV) in people with Airway Occlusion Pressure and Pressure Support Ventilation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad A Kandil, MSc (00201022644722, muhammad.kandil@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days (time frame: Day 28 after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.