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Completed

NCT Number: NCT02403791

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

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.

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Key information

Age range

1 day–31 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linear Ultrasonic Sounder

Device

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

Other names: Bedside Ultrasonography System

Bedside X-ray Machine

Device

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

Other names: Chest X-ray System

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Affiliated Hospital of Sichuan Vocational College of Health and Rehabilitation
  • 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 Sciences
  • The First Affiliated Hospital with Nanjing Medical University
  • The Sichuan Second Hospital of Guangxi Medical University
  • The Third Affiliated Hospital of Southern Medical University
  • The University of Science and Technology of China
  • The second affiliated hospital of Jinan University School of Medicine
  • Tsinghua University
  • Women and Children Health Hospital of Jiangsu Province
  • Yangzhou University

Registry information

Official study 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

Acronym: PoCBLUEPlus

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2015
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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