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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05272982
Other study ID # 35237/1/22
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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