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Not yet recruitingNCT07702422Updated Sep 18, 2026

The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation

An observational study in Liberation From Mechanical Ventilation, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

Approximately 20% of patients in the intensive care unit (ICU) requiring mechanical ventilation (MV) experience difficulty and prolonged weaning. Early spontaneous breathing trials (SBT) and timely extubation are essential to avoid complications such as diaphragmatic dysfunction, ventilator-associated pneumonia, and airway trauma.

Mechanical ventilation is a vital supportive therapy in critical care. However, both delayed weaning and premature discontinuation are associated with poor outcomes and prolonged ICU stay. Prolonged MV may lead to complications including respiratory muscle dysfunction, ventilator-associated lung injury, and increased healthcare costs, emphasizing the importance of optimal timing of weaning.

Ultrasonography (US) has emerged as a rapid, non-invasive bedside tool for real-time assessment of respiratory muscle function. It allows evaluation of muscle thickness and contractility, aiding in the detection of diaphragmatic dysfunction.

In cases of diaphragmatic impairment, accessory respiratory muscles, particularly the parasternal intercostal muscles, play a compensatory role. Measurement of parasternal intercostal muscle thickness fraction (PICTF%) has been proposed as a predictor of weaning failure.

Additionally, composite indices such as the rapid shallow breathing index (RSBI) and compliance, rate, oxygenation, and pressure (CROP) index are widely used to assess weaning readiness. A recently proposed composite index combining PICTF (>9%) and diaphragmatic excursion (\<15 mm) demonstrated high predictive value for failure of non-invasive ventilation.

Therefore, the present study aims to evaluate the effectiveness of this novel composite index in predicting weaning failure in mechanically ventilated patients.

02

Conditions studied

  • Liberation From Mechanical Ventilation

Keywords

  • weaning
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

  • All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
  • Neuromuscular diseases.
  • Severe head injury.
  • Pregnant and lactating women.

Inclusion criteria

  • Age ≥ 18 years old.
  • Both sexes.
  • Patients who have been mechanically ventilated for more than 48 h.

Exclusion criteria

Exclusion Criteria:

  • All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
  • Neuromuscular diseases.
  • Severe head injury.
  • Pregnant and lactating women.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
70 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Ability of a combined PICTF% and diaphragmatic excursion to predict weaning failure .

    Parasternal intercostal muscle thickening fraction (%) measured by ultrasound at 5 minutes after the start of the spontaneous breathing trial to evaluate its ability to predict weaning failure and diaphragmatic excursion

    Time frame: 5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail

Secondary outcomes

  1. • Difference between PICTF % at 5 and 60 min OF SBT. • RSBI at 5and 60 min of SBT. • Correlation between PICTF% and RSBI Diaphragmatic excursion

    Time frame: at 5 mintues of spontanous breathing trail and at 60 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07702422
Lead sponsor
Cairo University
Responsible party
Gehad Ahmed Mohamed Amer (assistant lecturer, Cairo University) — Principal investigator
First posted
Jul 14, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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