Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol
NCT ID: NCT02403791
Last Updated: 2015-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2014-03-31
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Lung Ultrasound
In infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography.
Linear Ultrasonic Sounder
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Chest Radiography
In infants allocated to this arm chest radiography will be performed for the detection of indirect signs of ARDS without ultrasound evaluation.
Bedside X-ray Machine
Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
Interventions
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Linear Ultrasonic Sounder
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Bedside X-ray Machine
Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In whom the treating Collaborative Review Groups of Poc-BLUE-Plus protocol believe would benefit from diagnostic imaging.
Exclusion Criteria
* Unstable infants with life-threatening injuries who require ongoing resuscitation
1 Day
31 Days
ALL
No
Sponsors
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The second affiliated hospital of Jinan University School of Medicine
UNKNOWN
First Affiliated Hospital of Chengdu Medical College
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Women and Children Health Hospital of Jiangsu Province
UNKNOWN
Affiliated Hospital of Sichuan Vocational College of Health and Rehabilitation
UNKNOWN
First Affiliated Hospital of Jinan University
OTHER
Yangzhou University
OTHER
The Third Affiliated Hospital of Southern Medical University
OTHER_GOV
The Sichuan Second Hospital of Guangxi Medical University
UNKNOWN
Guangzhou General Hospital
OTHER
Nankai University School of Medicine
OTHER
Guangdong Medical College
OTHER
Chongqing Medical University
OTHER
Tsinghua University
OTHER
Guiyang Medical University
OTHER
Shenzhen Institutes of Advanced Technology Chinese Academy of Science
UNKNOWN
Jiamusi University
UNKNOWN
The University of Science and Technology of China
OTHER
Nanjing Medical University
OTHER
Responsible Party
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Hong Liu
MD
Principal Investigators
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Jie Zhou, MD
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
References
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Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
Muscedere J, Dodek P, Keenan S, Fowler R, Cook D, Heyland D; VAP Guidelines Committee and the Canadian Critical Care Trials Group. Comprehensive evidence-based clinical practice guidelines for ventilator-associated pneumonia: diagnosis and treatment. J Crit Care. 2008 Mar;23(1):138-47. doi: 10.1016/j.jcrc.2007.12.008.
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
Other Identifiers
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PoC-BLUE-Plus One
Identifier Type: -
Identifier Source: org_study_id