Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol

Study Overview
=================
Brief 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.

Official Title
-----------------
A Prospective, Multi-center, Open-label and Double-blind, Standard-controlled, Non-inferiority, Diagnostic Study of Lung Ultrasound for Management of Mechanical Ventilation in Neonatal Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: Linear Ultrasonic Sounder
* Device: Bedside X-ray Machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants who present to the ICU with respiratory symptoms suspicious for ARDS, according to Pediatric Acute Respiratory Distress Syndrome: Consensus Recommendations From the Pediatric Acute Lung Injury Consensus Conference, which is proposed by The Pediatric Acute Lung Injury Consensus Conference Group. In whom the treating Collaborative Review Groups of Poc-BLUE-Plus protocol believe would benefit from diagnostic imaging. Exclusion Criteria: Infants who arrive at the ICU with a previously performed chest radiography Unstable infants with life-threatening injuries who require ongoing resuscitation

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 31 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Ultrasound<br>In infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography. | Device: Linear Ultrasonic Sounder<br>* Lung ultrasound evaluation is performed after clinical assessment and before chest radiography<br>* Other names: Bedside Ultrasonography System;|
| Active Comparator: Chest Radiography<br>In infants allocated to this arm chest radiography will be performed for the detection of indirect signs of ARDS without ultrasound evaluation. | Device: Bedside X-ray Machine<br>* Chest Radiography is performed after clinical evaluation without using ultrasound assessment.<br>* Other names: Chest X-ray System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Lung Ultrasound in Neonatal ARDS | Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available). | Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Lung Ultrasound in the Ventilator-Associated Pneumonia | Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available). | Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days | 
| Accuracy of Lung Ultrasound in the Weaning of Ventilatory Support | Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available). | Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Respiratory Distress Syndrome