Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning

May 27, 2025 updated by: Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Taha Taha Abd El Gawad
  • Phone Number: 01014008473

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Recruiting
        • Mohamed AbdElmoniem
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamed AbdElmoniem, Lecturer
        • Sub-Investigator:
          • Taha Taha Abd El Gawad, Professor
        • Sub-Investigator:
          • Tamer Awad Ibrahim, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University Hospital

Investigators

  • Principal Investigator: Mohamed AbdElmoniem, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R.24.05.2632

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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