Diaphragm Ultrasound in Weaning From Mechanical Ventilation

Abdominal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094299
• Other study ID #: N-16-2017
• Status: Completed
• First received: March 15, 2017
• Last updated: March 24, 2018
• Start date: April 1, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 23, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Sepsis
• Sepsis

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic thickening fraction	(calculated as maximum thickness - minimum thickness / maximum thickness)	five minutes before spontaneous breathing trial
Secondary	Diaphragmatic excursion	(measured in millimeters)	five minutes before spontaneous breathing trial and five minutes before patient extubation
Secondary	Rapid shallow breathing index (RSBI)	Respiratory rate/tidal volume in litres	five minutes before spontaneous breathing trial
Secondary	Arterial blood gases	Partial oxygen pressure and Partial carbon dioxide pressure	five minutes before spontaneous breathing trial and five minutes before patient extubation
Secondary	Number of weaning trials	number of weaning trials before this trial	during the last 7 days
Secondary	Heart rate	the patient heart rate measured as beat.minute	five minutes before spontaneous breathing trial and five minutes before patient extubation
Secondary	Arterial blood pressure	systolic and diastolic blood pressure measured in mmHg	five minutes before spontaneous breathing trial and five minutes before patient extubation