Clinical trial NCT05272982: Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound in Mechanically Ventilated Patients
Official title: Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound Score as Predictors of Weaning Outcome in Mechanically Ventilated Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Fluid Content
Electrical Cardiometry
Lung Ultrasound
Mechanical Ventilation
Intensive Care Unit
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score.
timeFrame: Two days after the extubation
Secondary outcomes:
measure: Prediction of weaning through rapid shallow breathing index (RSBI)
timeFrame: Two days after the extubation
measure: The degree of lung compliance
timeFrame: Before initiation of spontaneous breathing trial and before extubation.
measure: Cumulative fluid balance
timeFrame: within 24 hours of spontaneous breathing trial
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia Governorate, Egypt
Study officials:
References: