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Completed

NCT Number: NCT03094299

Diaphragm Ultrasound in Weaning From Mechanical Ventilation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diaphragmatic thickening fraction

    Time frame: five minutes before spontaneous breathing trial

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

Secondary outcomes

  1. Diaphragmatic excursion

    Time frame: five minutes before spontaneous breathing trial and five minutes before patient extubation

    (measured in millimeters)

  2. Rapid shallow breathing index (RSBI)

    Time frame: five minutes before spontaneous breathing trial

    Respiratory rate/tidal volume in litres

  3. 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

  4. Number of weaning trials

    Time frame: during the last 7 days

    number of weaning trials before this trial

  5. Heart rate

    Time frame: five minutes before spontaneous breathing trial and five minutes before patient extubation

    the patient heart rate measured as beat.minute

  6. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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