Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound in Mechanically Ventilated Patients
- Conditions
- Lung UltrasoundMechanical VentilationThoracic Fluid ContentElectrical CardiometryIntensive Care Unit
- Interventions
- Diagnostic Test: Thoracic fluid content by electrical cardiometry groupDiagnostic Test: Ultrasound examination group
- Registration Number
- NCT05272982
- Lead Sponsor
- Tanta University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Successful weaning group Ultrasound examination 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. Successful weaning group Thoracic fluid content by electrical cardiometry 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. Failed weaning group Thoracic fluid content by electrical cardiometry 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 ) Failed weaning group Ultrasound examination 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 )
- Primary Outcome Measures
Name Time Method 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 extubation 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.
- Secondary Outcome Measures
Name Time Method The degree of lung compliance Before 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.Prediction of weaning through rapid shallow breathing index (RSBI) Two days after the extubation 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.
Cumulative fluid balance within 24 hours of spontaneous breathing trial Cumulative fluid balance at the day of spontaneous breathing trial (equals the total fluid intake minus the fluid output) will be recorded.
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, El-Gharbia Governorate, Egypt, Egypt