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Clinical Trials/NCT03094299
NCT03094299
Completed
Not Applicable

The Efficacy of Ultrasound Assessment of Diaphragmatic Function in Guiding Weaning From Mechanical Ventilation in Critically Ill Patients With Abdominal Sepsis

Cairo University1 site in 1 country30 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Sepsis
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Diaphragmatic thickening fraction
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
March 23, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Hasanin

Prinicpal investigator, Lecturer of anesthesia and critical care medicine

Cairo University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diaphragmatic thickening fraction

Time Frame: five minutes before spontaneous breathing trial

(calculated as maximum thickness - minimum thickness / maximum thickness)

Secondary Outcomes

  • Diaphragmatic excursion(five minutes before spontaneous breathing trial and five minutes before patient extubation)
  • Rapid shallow breathing index (RSBI)(five minutes before spontaneous breathing trial)
  • Arterial blood gases(five minutes before spontaneous breathing trial and five minutes before patient extubation)
  • Number of weaning trials(during the last 7 days)
  • Heart rate(five minutes before spontaneous breathing trial and five minutes before patient extubation)
  • Arterial blood pressure(five minutes before spontaneous breathing trial and five minutes before patient extubation)

Study Sites (1)

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