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

T

Tanta University

Status

Completed

Conditions

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

Treatments

Diagnostic Test: Ultrasound examination group
Diagnostic Test: Thoracic fluid content by electrical cardiometry group

Study type

Observational

Funder types

Other

Identifiers

NCT05272982
35237/1/22

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

85 participants in 2 patient groups

Successful weaning group
Description:
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.
Treatment:
Diagnostic Test: Thoracic fluid content by electrical cardiometry group
Diagnostic Test: Ultrasound examination group
Failed weaning group
Description:
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 )
Treatment:
Diagnostic Test: Thoracic fluid content by electrical cardiometry group
Diagnostic Test: Ultrasound examination group

Trial contacts and locations

1

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Central trial contact

Esraa Amer, MSc

Data sourced from clinicaltrials.gov

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