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RecruitingNCT06465082Updated May 29, 2025

Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning

An observational study in Weaning From Mechanical Ventilation, sponsored by Mansoura University Hospital. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Mansoura University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.

Read the detailed description

Timing is critical for proper weaning for patients undergoing mechanical ventilation; if this is performed prematurely complications can include increased cardiovascular and respiratory stress, CO2 retention and hypoxemia. However, unnecessary delay in weaning can also cause a number of side-effects.Weaning outcomes have been assessed by several indices. Variables such as minute ventilation, Pao2/Fio2, rapid shallow breathing index and static compliance have all been used, with variable predictive values. Previous studies have proved that diaphragmatic dysfunction is one of the main etiologies of difficult weaning, because the diaphragm progressively weakens with mechanical ventilation.Methods used to assess diaphragm function, such as fluoroscopy, phrenic nerve stimulation, measurement of trans-diaphragmatic pressure and dynamic magnetic resonance imaging of the diaphragm, all have limitations. These include ionizing radiation exposure, low availability, invasiveness and necessity for patient transportation. Conversely, the use of ultrasound is safe, non-invasive, avoids radiation side-effects, and is available at the bedside.The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.

02

Conditions studied

  • Weaning From Mechanical Ventilation

Keywords

  • mechanical ventilation.
  • diaphragmatic thickening Fraction
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In context

Lead sponsor

Mansoura University Hospital is the lead sponsor of 50 studies on the registry; 7 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients >18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate > 30 breath/min, Disturbed conscious level.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients >18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate > 30 breath/min, Disturbed conscious level.

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years.
  • Pregnancy
  • Surgical incisions likely to interfere with ultrasound examination.
  • Hepato-splenomegaly, Ascites
  • Neuromuscular disease as Myasthenia gravis, kypho-scoliosis
  • Diaphragmatic Paralysis (paralyzed diaphragm exhibiting abnormal paradoxical movement, i.e., moving in a cranial direction during inspiration
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
55 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Diaphragmatic thickening Fraction as predictor for weaning from mechanical ventilation.

    assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.

    Time frame: Baseline and after 6 month

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06465082
Lead sponsor
Mansoura University Hospital
Responsible party
Mohamed Abd Elmoniem Mohamed (Lecturer of chest medicine, Mansoura University Hospital) — Principal investigator
First posted
Jun 18, 2024
Start date
Sep 5, 2024
Primary completion
Jul 15, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
May 29, 2025

Study contacts

Mohamed AbdElmoniem
Contact
dr.m1993@mans.edu.eg
01014008473
Taha Taha Abd El Gawad
Contact
01014008473
Mohamed AbdElmoniem
principal investigator · Mansoura University

Oversight

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

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