- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094299
Diaphragm Ultrasound in Weaning From Mechanical Ventilation
The Efficacy of Ultrasound Assessment of Diaphragmatic Function in Guiding Weaning From Mechanical Ventilation in Critically Ill Patients With Abdominal Sepsis
Study Overview
Status
Conditions
Detailed Description
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume); however, sensitivity and specificity for most variables are still variable in literature.
Diaphragmatic dysfunction is a common cause of weaning failure (2) however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening. In this study we will evaluate the ability of the diaphragmatic function to predict weaning success in patients with abdominal sepsis.
After weaning, patients will be divided into two groups; group of successful weaning (group S) and group with failed weaning (group F) both groups will be compared as regards all clinical, laboratory, and ultrasonographic parameters recorded before weaning, further analysis will be done for patients with repeated trials of weaning (more than one trial or more than one week MV) and those with simple weaning (first time for weaning).
A 7-10 Mega Hertz linear ultrasound probe (Mindray machine) set to B mode, the diaphragm will be visualized by placing the transducer perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and the midaxillary lines, to observe the zone of apposition of the muscle 0.5 to 2 cm below the costophrenic sinus.
The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then, the diaphragmatic fraction thickening (DTF) will be calculated as percentage Diaphragmatic movement will be measured in all patients with a 3.5 Mega Hertz US probe placed over one of the lower intercostal spaces in the right anterior axillary line for the right diaphragm and the left midaxillary line for the left diaphragm.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Critically ill patients with abdominal sepsis with history of MV for more than 48 hours
Exclusion Criteria:
- Age < 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. Also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragmatic thickening fraction
Time Frame: five minutes before spontaneous breathing trial
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(calculated as maximum thickness - minimum thickness / maximum thickness)
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five minutes before spontaneous breathing trial
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragmatic excursion
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
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(measured in millimeters)
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five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Rapid shallow breathing index (RSBI)
Time Frame: five minutes before spontaneous breathing trial
|
Respiratory rate/tidal volume in litres
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five minutes before spontaneous breathing trial
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Arterial blood gases
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
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Partial oxygen pressure and Partial carbon dioxide pressure
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Number of weaning trials
Time Frame: during the last 7 days
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number of weaning trials before this trial
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during the last 7 days
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Heart rate
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
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the patient heart rate measured as beat.minute
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Arterial blood pressure
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
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systolic and diastolic blood pressure measured in mmHg
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-16-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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