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NCT Number: NCT06465082

Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location status: Recruiting

Location contact

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

Mohamed AbdElmoniem, Lecturer

PRINCIPAL_INVESTIGATOR

Taha Taha Abd El Gawad, Professor

SUB_INVESTIGATOR

Tamer Awad Ibrahim, Lecturer

SUB_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline and after 6 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

Taha Taha Abd El Gawad

CONTACT

01014008473

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

Role of Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning From Mechanical Ventilation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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