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Completed

NCT Number: NCT05272982

Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound in Mechanically Ventilated Patients

This study aims to compare the accuracy of the total thoracic fluid content (TFC) measured by electrical cardiometry with accuracy of lung ultrasound score in prediction of weaning outcome in mechanically ventilated patients.

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Key information

Conditions

Thoracic Fluid Content Electrical Cardiometry Intensive Care Unit Lung Ultrasound Mechanical Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

About this study

Weaning of patients from mechanical ventilation remains one of the critical decisions in the intensive care unit. Earlier patient weaning from mechanical ventilation is recommended to avoid complications of prolonged mechanical ventilation; however, premature weaning might result in extubation failure which is, independently, associated with poor outcomes.

Screening for eligibility is the first step in the weaning process, followed by the spontaneous breathing trial (SBT). Various indices should be checked carefully before starting a spontaneous breathing trial to ensure adequate oxygenation, ventilation, and airway reflexes. However, nearly one-third of patients fail and are reintubated despite fulfillment of all the current weaning pre-requisites.

Who can participate

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

Inclusion criteria

  • 85 mechanically ventilated patients for ≥ 48 hours
  • Aged 18-65 years
  • Both sex
  • Fulfilled the weaning readiness criteria
  • Scheduled for spontaneous breathing trial (SBT) using pressure support ventilation.

Exclusion criteria

  • Acute respiratory distress syndrome (ARDS) patients.
  • Interstitial lung fibrosis.
  • Patients with lung resection.
  • Pulmonary embolism.
  • Patients with fluid overload due to heart, renal or hepatic failure.
  • Cardiac patients with ejection fraction less than 40%, cardiomyopathy, congenital or valvular heart diseases.
  • Pneumothorax.
  • Pleural or pericardial effusion.
  • Pregnancy.
  • Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes or the ultrasound transducer.

Treatment and study plan

Thoracic fluid content by electrical cardiometry group

Diagnostic Test

Thoracic fluid content will be measured using electrical cardiometry device (ICON ® Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). The ICON device will be connected to four electrocardiogram electrodes which will be placed over patients' skin after cleaning with alcohol at the neck below the left ear, just above the left clavicular midpoint, and two electrodes at left mid-axillary line one at the level of the xiphoid process, and the other electrode 5 cm below this point. The thoracic fluid content will be observed for 30 s and the average of the highest and lowest values will be recorded.

Ultrasound examination group

Diagnostic Test

The 12-region technique for lung assessment will be performed using Philips ® (CX50 - Extreme edition) equipped with phased array transducer. B-line will be defined as laser like vertical hyperechoic artefact which extends between the pleural line and the bottom of the screen and moves with respiratory movements. Two types of B-lines will be evaluated.

Primary outcomes

  1. Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score.

    Time frame: Two days after the extubation

    Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score (minimum score, normal lungs: 0; maximum score, both consolidated lungs: 36) in prediction of weaning outcome in mechanically ventilated patients.

Secondary outcomes

  1. Prediction of weaning through rapid shallow breathing index (RSBI)

    Time frame: Two days after the extubation

    Rapid shallow breathing index (RSBI) [respiratory rate/tidal volume (in liters)] will be recorded before the initiation of spontaneous breathing trial (SBT) and before extubation.

  2. The degree of lung compliance

    Time frame: Before initiation of spontaneous breathing trial and before extubation.

    Lung compliance will be recorded before initiation of spontaneous breathing trial and before extubation.

    It is defined as the measure of the lung's ability to stretch and expand (distensibility of elastic tissue) and is calculated using the equation (V/ΔP; where ΔV is the change in volume, and ΔP is the change in pleural pressure.

  3. Cumulative fluid balance

    Time frame: within 24 hours of spontaneous breathing trial

    Cumulative fluid balance at the day of spontaneous breathing trial (equals the total fluid intake minus the fluid output) will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound Score as Predictors of Weaning Outcome in Mechanically Ventilated Intensive Care Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2022
Registry last updated
Apr 15, 2025

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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