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

NCT02403791 | Completed DMC

• 1 other identifier: PoC-BLUE-Plus One
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of Lung Ultrasound in the Ventilator-Associated Pneumonia

  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 will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days

Study Arms (2)

Lung Ultrasound

EXPERIMENTAL

In infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography.

Device: Linear Ultrasonic Sounder

Chest Radiography

ACTIVE COMPARATOR

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

Interventions

Linear Ultrasonic Sounder DEVICE

Lung ultrasound evaluation is performed after clinical assessment and before chest radiography

Also known as: Bedside Ultrasonography System

Lung Ultrasound

Bedside X-ray Machine DEVICE

Chest Radiography is performed after clinical evaluation without using ultrasound assessment.

Also known as: Chest X-ray System

Chest Radiography

Eligibility Criteria

• Age: 1 Day - 31 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants who arrive at the ICU with a previously performed chest radiography
• Unstable infants with life-threatening injuries who require ongoing resuscitation

Sponsors & Collaborators

• Nanjing Medical University: lead
• The second affiliated hospital of Jinan University School of Medicine: collaborator
• First Affiliated Hospital of Chengdu Medical College: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Women and Children Health Hospital of Jiangsu Province: collaborator
• Affiliated Hospital of Sichuan Vocational College of Health and Rehabilitation: collaborator
• First Affiliated Hospital of Jinan University: collaborator
• Yangzhou University: collaborator
• The Third Affiliated Hospital of Southern Medical University: collaborator
• The Sichuan Second Hospital of Guangxi Medical University: collaborator
• Guangzhou General Hospital: collaborator
• Nankai University School of Medicine: collaborator
• Guangdong Medical College: collaborator
• Chongqing Medical University: collaborator
• Tsinghua University: collaborator
• Guiyang Medical University: collaborator
• Shenzhen Institutes of Advanced Technology Chinese Academy of Science: collaborator
• Jiamusi University: collaborator
• The University of Science and Technology of China: collaborator

Related Publications (4)

• 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.

  PMID: 25647235 RESULT

• 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.

  PMID: 18359431 RESULT

• 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.

  PMID: 22797452 RESULT

• 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.

  PMID: 11742959 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jie Zhou, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 31, 2015

Record last verified: 2015-03