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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05272982
Enrollment
85
Registered
2022-03-10
Start date
2022-03-25
Completion date
2023-12-25
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTThoracic 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.

DIAGNOSTIC_TESTUltrasound 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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score.Two days after the extubationComparing 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

MeasureTime frameDescription
Prediction of weaning through rapid shallow breathing index (RSBI)Two days after the extubationRapid shallow breathing index (RSBI) \[respiratory rate/tidal volume (in liters)\] will be recorded before the initiation of spontaneous breathing trial (SBT) and before extubation.
The degree of lung complianceBefore 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.
Cumulative fluid balancewithin 24 hours of spontaneous breathing trialCumulative fluid balance at the day of spontaneous breathing trial (equals the total fluid intake minus the fluid output) will be recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026