NCT07709182

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Jan 2028

Study Start

First participant enrolled

February 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 11, 2026

Last Update Submit

July 11, 2026

Conditions

Airway Occlusion PressurePressure Support VentilationConventional ManagementWeaning Window Patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Duration of Mechanical Ventilation

    Till final successful extubation (Up to 48 hours)

  • Length of stay in the intensive care unit

    Till the discharge from intensive care unit (Up to 28 days)

  • Patient-Ventilator Asynchrony Index (PVAI)

    Day 28 after the procedure

  • Dexmedetomidine requirement

    Day 28 after the procedure

  • Failed weaning

    48 hours after extubation

Study Arms (2)

Group I (Control Group)

ACTIVE COMPARATOR

Patients will receive a conventional pressure support ventilation protocol.

Other: Pressure support ventilation protocol

Group II (Study Group)

EXPERIMENTAL

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

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

Interventions

Pressure support ventilation protocolOTHER

Patients will receive a conventional pressure support ventilation protocol.

Group I (Control Group)
Airway occlusion pressure (P0.1)-guided pressure support ventilation (PSV)OTHER

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

Group II (Study Group)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Al Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Muhammad A Kandil, MSc

CONTACT

00201022644722muhammad.kandil@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Egypt.

Study Record Dates

First Submitted

July 11, 2026

First Posted

July 16, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)