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

NCT05272982 | Completed

• 1 other identifier: 35237/1/22
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Two days after the extubation

Secondary Outcomes (3)

• Prediction of weaning through rapid shallow breathing index (RSBI)

  Two days after the extubation

• The degree of lung compliance

  Before initiation of spontaneous breathing trial and before extubation.

• Cumulative fluid balance

  within 24 hours of spontaneous breathing trial

Study Arms (2)

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.

Diagnostic Test: Thoracic fluid content by electrical cardiometry group; Diagnostic Test: Ultrasound examination group

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 )

Diagnostic Test: Thoracic fluid content by electrical cardiometry group; Diagnostic Test: Ultrasound examination group

Interventions

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.

Failed weaning group; Successful weaning group

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.

Failed weaning group; Successful weaning group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

85 mechanically ventilated patients for ≥ 48 hours aged 18 years or more of both sex who fulfilled the weaning readiness criteria and scheduled for spontaneous breathing trial using pressure support ventilation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

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

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: March 25, 2022
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available after the study and for 5 years after.

Locations

EG (1)