Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning

NCT ID: NCT06465082

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-05

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Weaning From Mechanical Ventilation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abd Elmoniem Mohamed

Lecturer of chest medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed AbdElmoniem

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mohamed AbdElmoniem

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed AbdElmoniem

Role: CONTACT

01014008473

Taha Taha Abd El Gawad

Role: CONTACT

01014008473

Facility Contacts

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Mohamed AbdElmoniem

Role: primary

01014008473

Role: backup

Other Identifiers

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R.24.05.2632

Identifier Type: -

Identifier Source: org_study_id

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