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

NCT ID: NCT05272982

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2023-12-25

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Successful weaning group

Criteria of weaning included resolution of the primary cause of intubation, adequate cough without excessive tracheobronchial secretions, PaO2 \> 60 mmHg with positive end-expiratory pressure ≤ 8 cmH2O, fraction of inspired oxygen ≤ 0.4, respiratory rate \< 30 per minute, appropriate pH for patients' baseline respiratory status, and stable cardiovascular status.

Thoracic fluid content by electrical cardiometry group

Intervention Type: 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

Intervention Type: 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.

Failed weaning group

Weaning failure will be defined as a patient need for reintubation or noninvasive ventilation within 48 h after extubation due to the presence of one or more of the following criteria: altered mental status tachypnea (respiratory rate more than 35 breaths per minute), oxygen saturation less than 90% or PaO2 less than 60 mmHg on a fraction of inspired oxygen of 40%, an apparent increase in accessory respiratory muscle activity, evident facial signs of respiratory distress and hemodynamic instability (Heart rate \>140 b/min, systolic blood pressure \>180 or \< 90mmHg )

Thoracic fluid content by electrical cardiometry group

Intervention Type: 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

Intervention Type: 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.

Interventions

Thoracic fluid content by electrical cardiometry group

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.

Intervention Type: DIAGNOSTIC_TEST

Ultrasound examination group

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Rabie Amer

Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia Governorate, Egypt, Egypt

Countries

Egypt

Other Identifiers

35237/1/22

Identifier Type: -

Identifier Source: org_study_id