Diaphragm Ultrasound in Weaning From Mechanical Ventilation

Completed

• Conditions: Abdominal Sepsis

• Registration Number: NCT03094299
• Lead Sponsor: Cairo University

Brief Summary

This study aims to evaluate the efficacy of ultrasound derived variables in prediction of success of weaning from mechanical ventilation in critically ill patients with abdominal sepsis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Study Start: 2017-04-01
• Status Verified: 2018-03
• Primary Completion: 2018-03-21
• Study Completion: 2018-03-23
• Last Update Submitted: 2018-03-24
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Critically ill patients with abdominal sepsis with history of MV for more than 48 hours

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragmatic thickening fraction	five minutes before spontaneous breathing trial	(calculated as maximum thickness - minimum thickness / maximum thickness)

Secondary Outcome Measures

Name	Time	Method
Diaphragmatic excursion	five minutes before spontaneous breathing trial and five minutes before patient extubation	(measured in millimeters)
Rapid shallow breathing index (RSBI)	five minutes before spontaneous breathing trial	Respiratory rate/tidal volume in litres
Arterial blood gases	five minutes before spontaneous breathing trial and five minutes before patient extubation	Partial oxygen pressure and Partial carbon dioxide pressure
Number of weaning trials	during the last 7 days	number of weaning trials before this trial
Heart rate	five minutes before spontaneous breathing trial and five minutes before patient extubation	the patient heart rate measured as beat.minute
Arterial blood pressure	five minutes before spontaneous breathing trial and five minutes before patient extubation	systolic and diastolic blood pressure measured in mmHg

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt