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

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05272982
• Other study ID #: 35237/1/22
• Status: Not yet recruiting
• Start date: March 25, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: February 2022
• Source: Tanta University
• Contact: Esraa Amer, MSc
• Phone: +201095917066
• Email: esraa.rabiea[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: February 25, 2023
• Est. primary completion date: February 25, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Electrical Cardiometry
• Intensive Care Unit
• Lung Ultrasound
• Mechanical Ventilation

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prediction of weaning through rapid shallow breathing index (RSBI)	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.	Two days after the extubation
Secondary	The degree of lung compliance	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/?P; where ?V is the change in volume, and ?P is the change in pleural pressure.	Before initiation of spontaneous breathing trial and before extubation.
Secondary	Cumulative fluid balance	Cumulative fluid balance at the day of spontaneous breathing trial (equals the total fluid intake minus the fluid output) will be recorded.	within 24 hours of spontaneous breathing trial