Diaphragm Ultrasound in Weaning From Mechanical Ventilation

March 24, 2018 updated by: Ahmed Hasanin, Cairo University

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

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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients with abdominal sepsis.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
(calculated as maximum thickness - minimum thickness / maximum thickness)
five minutes before spontaneous breathing trial

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
(measured in millimeters)
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
five minutes before spontaneous breathing trial
Arterial blood gases
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
Partial oxygen pressure and Partial carbon dioxide pressure
five minutes before spontaneous breathing trial and five minutes before patient extubation
Number of weaning trials
Time Frame: during the last 7 days
number of weaning trials before this trial
during the last 7 days
Heart rate
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
the patient heart rate measured as beat.minute
five minutes before spontaneous breathing trial and five minutes before patient extubation
Arterial blood pressure
Time Frame: five minutes before spontaneous breathing trial and five minutes before patient extubation
systolic and diastolic blood pressure measured in mmHg
five minutes before spontaneous breathing trial and five minutes before patient extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

March 21, 2018

Study Completion (Actual)

March 23, 2018

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 24, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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