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Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol (PoCBLUEPlus)

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ClinicalTrials.gov Identifier: NCT02403791
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Collaborators:
The second affiliated hospital of Jinan University School of Medicine
First Affiliated Hospital of Chengdu Medical College
The First Affiliated Hospital with Nanjing Medical University
Women and Children Health Hospital of Jiangsu Province
Affiliated Hospital of Sichuan Vocational College of Health and Rehabilitation
First Affiliated Hospital of Jinan University
Yangzhou University
The Third Affiliated Hospital of Southern Medical University
The Sichuan Second Hospital of Guangxi Medical University
Guangzhou General Hospital
Nankai University School of Medicine
Guangdong Medical College
Chongqing Medical University
Tsinghua University
Guiyang Medical University
Shenzhen Institutes of Advanced Technology Chinese Academy of Science
Jiamusi University
The University of Science and Technology of China
Information provided by (Responsible Party):
Hong Liu, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: Linear Ultrasonic Sounder Device: Bedside X-ray Machine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: Lung Ultrasound
In infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography.
Device: Linear Ultrasonic Sounder
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Other Name: Bedside Ultrasonography System

Active Comparator: Chest Radiography
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
Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
Other Name: Chest X-ray System




Primary Outcome Measures :
  1. Accuracy of Lung Ultrasound in Neonatal ARDS [ Time Frame: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days ]
    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).


Secondary Outcome Measures :
  1. Accuracy of Lung Ultrasound in the Ventilator-Associated Pneumonia [ Time Frame: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days ]
    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).

  2. Accuracy of Lung Ultrasound in the Weaning of Ventilatory Support [ Time Frame: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 31 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403791


Sponsors and Collaborators
Nanjing Medical University
The second affiliated hospital of Jinan University School of Medicine
First Affiliated Hospital of Chengdu Medical College
The First Affiliated Hospital with Nanjing Medical University
Women and Children Health Hospital of Jiangsu Province
Affiliated Hospital of Sichuan Vocational College of Health and Rehabilitation
First Affiliated Hospital of Jinan University
Yangzhou University
The Third Affiliated Hospital of Southern Medical University
The Sichuan Second Hospital of Guangxi Medical University
Guangzhou General Hospital
Nankai University School of Medicine
Guangdong Medical College
Chongqing Medical University
Tsinghua University
Guiyang Medical University
Shenzhen Institutes of Advanced Technology Chinese Academy of Science
Jiamusi University
The University of Science and Technology of China
Investigators
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Study Director: Jie Zhou, MD The First Affiliated Hospital with Nanjing Medical University
Publications of Results:
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Responsible Party: Hong Liu, MD, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02403791    
Other Study ID Numbers: PoC-BLUE-Plus One
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Hong Liu, Nanjing Medical University:
Acute Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury