Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning

Weaning From Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465082
• Other study ID #: R.24.05.2632
• Status: Recruiting
• Start date: June 5, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: June 2024
• Source: Mansoura University Hospital
• Contact: Mohamed AbdElmoniem
• Phone: 01014008473
• Email: dr.m1993[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: November 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weaning From Mechanical Ventilation

Locations

Country	Name	City	State
Egypt	Mohamed AbdElmoniem	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after 6 month