Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the availability and diagnostic accuracy of
      point-of-care bedside lung ultrasound examination in management of mechanical ventilation in
      neonatal acute respiratory distress syndrome.
    

Detailed description: 
      Neonatal acute respiratory distress syndrome (ARDS) is a critical condition requiring dynamic
      evaluation and interventions. Point-of-care bedside lung ultrasound examination (PoC-BLUE) is
      a noninvasive, readily available imaging modality that can complement physical and clinical
      evaluation.

      At any time, most neonates and infants with ARDS in medical intensive care units (ICUs)
      require mechanical ventilation, making it one of the most frequently used critical care
      technologies. However, difficulties with regard to the accurate diagnosis of ARDS before
      administration of mechanical ventilation, dynamic monitoring of treatment effects during
      administration of mechanical ventilation, and decision-making of timing in weaning from
      mechanical ventilation, are often encountered in the majority neonates and infants who
      require mechanical ventilation.

      Hence, techniques that expedite and advance the knowledge of the administration of mechanical
      ventilation should have an important clinical significance in the diagnosis, treatment and
      prognosis of ARDS.

      Preliminary researches have suggested that BLUE has a high diagnostic accuracy in patients
      with acute respiratory failure, and has the potential to quantify the rate and degree of
      diaphragm thinning during mechanical ventilation, which may be useful to predict extubation
      success or failure during either spontaneous breathing (SB) or pressure support (PS) trials.

      Unfortunately, few studies focus on the availability of PoC-BLUE in management of mechanical
      ventilation in neonatal acute respiratory distress syndrome. Also, they call into question
      the possible association of the demographic and clinical confounders with the diagnostic
      accuracy of PoC-BLUE for diagnosis, monitoring and prognosis of ARDS in the whole process of
      mechanical ventilation.

      Given that a considerable need for a timely and dynamic diagnosis of severe condition and
      therapy evaluation during mechanical ventilation has been triggered to integrate the
      currently available bulk of knowledge and information, the objective of this study is to
      investigate the availability and diagnostic accuracy of PoC-BLUE Plus protocol in management
      of mechanical ventilation in ARDS.
    

Intervention name(s): Linear Ultrasonic Sounder; Bedside X-ray Machine
Intervention type(s): Device; Device
Intervention description(s): Lung ultrasound evaluation is performed after clinical assessment and before chest radiography; Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
Other intervention name(s): Bedside Ultrasonography System; Chest X-ray System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Acute Respiratory Distress Syndrome