- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630662
Effectiveness of Diaphragmatic Function and Parasternal Intercostal Muscles Functions as Predictors for Successful Weaning From Mechanical Ventilation
Ultrasound Evaluation of Diaphragmatic Functions and Parasternal Intercostal Muscle Thickening Fraction as Predictors of Successful Weaning From Mechanical Ventilation.
Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. that is besides complications such as barotrauma, ventilator-acquired pneumonia, accumulation of secretions, and lung atelectasis.
The ultrasound estimation of parasternal intercostal muscle and diaphragmatic functions is a method to evaluate if there is a good chance of weaning outcomes.
Study Overview
Status
Conditions
Detailed Description
Mechanical ventilation is a commonly used therapeutic strategy in the Intensive care unit (ICU) by providing adequate oxygenation and ventilation until improvement of the patient's condition.
Serious consequences usually follow prolonged mechanical ventilation (MV) such as barotraumas and ventilator-associated pneumonia.
On the other hand, early discontinuation of ventilation is associated with adverse cardiovascular events. Therefore, time of extubation should be anticipated properly.
Respiratory muscle dysfunction is one of the leading reasons for difficult to wean population.
There is growing evidence about the use of diaphragmatic ultrasound in evaluating both need for and weaning from mechanical ventilation. However, diaphragmatic ultrasound carry some drawbacks such as lack of echogenicity and difficult to examine left side.
Extra-diaphragmatic muscles (including parasternal intercostal muscles, scalene muscles, and sternocleidomastoid) act hand-in-hand with diaphragm to complete mechanical pump actions therefore in case of diaphragmatic dysfunction accessory respiratory muscles increase their work. This could be a possible compensatory mechanism.
Evidence support the use of parasternal intercostal muscles as a predictor of need and weaning from mechanical ventilation with perfect inter-observer reliability that could provide further details about respiratory capacity/load harmony.
We, therefore, decided to study ultrasound assessment of these muscles during weaning from MV in critically ill patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed I Ezz Eldein
- Phone Number: +2-1148394581
- Email: mohamedislam@med.asu.edu.eg
Study Locations
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Cairo, Egypt
- Recruiting
- Ain shams university hospitals
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Contact:
- Mohamed I Ezz Eldein
- Phone Number: +2-1148394581
- Email: mohamedislam@med.asu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. Adult patients more than 18 years old. 2. Patient on mechanical ventilation more than 48 hours.
Exclusion Criteria:
- 1. Declining to give a written informed consent. 2. Diaphragmatic paralysis or injury
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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diaphragmatic and parasternal muscles function assessment
Patients who fulfilling the initial parameters for possibility of weaning will undergo spontaneous breathing trial (SBT) for 30 minutes. All patients will be positioned in a semi sitting position at approximately 30 degree, and will be monitored closely during SBT period. Ultrasound assessment for the parasternal intercostal and diaphragmatic muscle functions will be done at the end of SBTs for all patients. Ultrasound assessment of diaphragm: Diaphragmatic excursion; The diaphragmatic movement will be measured using a 3.5-MHz ultrasound probe. With the probe fixed on the chest wall during respiration, the patient will be asked to take a maximum breath. The right hemi-diaphragm will be measured by positioning the probe between the mid-clavicular and mid-axillary lines below the right costal margin (subcostal approach) using the liver as acoustic window. The probe will be positioned medially, cephalic and dorsally. Till the hemi-diaphragm will be well visualized. The M-mood will be ap |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ultrasound guided muscles function assessment
Time Frame: 30-60 minutes
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- Evaluation of the efficacy of diaphragmatic and parasternal intercostal muscle functions as a predictors of successful weaning from mechanical ventilation.
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30-60 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMASU MD194a/2024/2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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