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

Acute Respiratory Distress Syndrome Clinical Trial

— PoCBLUEPlus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403791
• Other study ID #: PoC-BLUE-Plus One
• Status: Completed
• Phase: N/A
• First received: March 22, 2015
• Last updated: March 25, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Data safety and monitoring board (DSMB) of the PoC-BLUE-Plus Protocol
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 31 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (19)

Lead Sponsor

Collaborator

Nanjing Medical University

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

References & Publications (4)

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. — View Citation

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 f — View Citation

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 Cr — View Citation

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.0000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes