Acute Respiratory Distress SyndromePoCBLUEPlusNCT02403791
Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol
A study testing Linear Ultrasonic Sounder and Bedside X-ray Machine in people with Acute Respiratory Distress Syndrome, run by Nanjing Medical University.
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. Read more about this study
- Who is it for?
- Ages 1 day to 31 days
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Linear Ultrasonic Sounder and Bedside X-ray Machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 31 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Infants who arrive at the ICU with a previously performed chest radiography
- Unstable infants with life-threatening injuries who require ongoing resuscitation
About this study
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
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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Linear Ultrasonic Sounder, Bedside X-ray Machine
- Keywords
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Ultrasonic SounderDevice
Also called Bedside Ultrasonography System
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Bedside X-ray MachineDevice
Also called Chest X-ray System
Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
| Study group | Role | What they receive |
|---|---|---|
| Lung Ultrasound | Experimental | In infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography. Receives: 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. Receives: Device: Bedside X-ray Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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).
Measured: 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 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).
Measured: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- 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 Sciences, Jiamusi University, The University of Science and Technology of China
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Jie Zhou, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403791
- Sponsor's protocol ID
- PoC-BLUE-Plus One
- Acronym
- PoCBLUEPlus
- Status last verified
- Mar 2015
- First submitted
- 22 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25647235Muscedere 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.
PubMed 18359431ARDS 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.
PubMed 22797452MacIntyre 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.
PubMed 11742959
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02403791
- Acronym / sponsor ID
- PoCBLUEPlus / PoC-BLUE-Plus One
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- 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 Sciences, Jiamusi University, The University of Science and Technology of China
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasound | Experimental | Device: Linear Ultrasonic SounderIn infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography. |
| Chest Radiography | Active comparator | Device: Bedside X-ray MachineIn infants allocated to this arm chest radiography will be performed for the detection of indirect signs of ARDS without ultrasound evaluation. |
Who may qualify
- Ages
- 1 day to 31 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Infants who arrive at the ICU with a previously performed chest radiography
- Unstable infants with life-threatening injuries who require ongoing resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linear Ultrasonic SounderAlso: Bedside Ultrasonography SystemLung ultrasound evaluation is performed after clinical assessment and before chest radiography | Device | Lung Ultrasound |
| Bedside X-ray MachineAlso: Chest X-ray SystemChest Radiography is performed after clinical evaluation without using ultrasound assessment. | Device | Chest Radiography |
Primary outcome
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).
2 secondary outcomes
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Results publication: PubMed 25647235Pediatric 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.
- Results publication: PubMed 18359431Muscedere 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.
- Results publication: PubMed 22797452ARDS 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.
- Results publication: PubMed 11742959MacIntyre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Zhou, MD study director
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Linear Ultrasonic Sounder and Bedside X-ray Machine in people with Acute Respiratory Distress Syndrome, run by Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403791, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.