Pediatric Respiratory DiseasesNCT03744169
Use of Lung Ultrasound to Diagnose the Etiology of Respiratory Failure in a PICU.
An observational study of Pediatric Respiratory Diseases and Respiratory Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine the utility of point-of-care lung ultrasound (POC-LUS) in identifying the etiology of acute respiratory failure in pediatric patients admitted to the pediatric intensive care unit. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Respiratory Diseases, Respiratory Failure
- What is being tested?
- Lung ultrasound, Clinical exam and Chest x-ray
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 29 Feb 2020
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients age greater than 37 weeks gestational age and less than 18 years old with a clinical diagnosis of acute respiratory failure and the need for non-invasive (HFNC > 1 L/kg/min, CPAP, or BiPAP) or invasive mechanical ventilation.
Who may be able to join
- Age greater than 37 weeks gestational age and less than 18 years
- Admitted to PICU
- Clinical diagnosis of acute respiratory failure
- Requirement of non-invasive or invasive respiratory support (as defined by a clinical need for high flow nasal cannula >1L/kg/min; RAM cannula, nasal or full face mask delivered continuous positive airway pressure ventilation; RAM cannula, nasal or full face mask delivered bi-level positive airway pressure ventilation; or invasive mechanical ventilation); requirement of supplemental oxygen with FiO2 > 0.35 while on high flow nasal cannula <1L/kg/min to maintain saturations > 90%; continuous nebulized therapy; or chronic use of home oxygen or ventilator support AND any increase in home settings
Who cannot join
- Hemodynamically unstable as defined by the initiation of or the need for increased vasopressor support within the previous 30 minutes
- Known chronic respiratory disease such as primary ciliary dyskinesia, cystic fibrosis, or congenital pulmonary malformations.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, American Family Children's Hospital
Madison, Wisconsin, 53792
About this study
Official title: Use of Point-of-care Lung Ultrasound to Diagnose the Etiology of Acute Respiratory Failure in a Pediatric Intensive Care Unit.
The purpose of this study is to determine the utility of point-of-care lung ultrasound (POC-LUS) in identifying the etiology of acute respiratory failure in pediatric patients admitted to the pediatric intensive care unit.
Read the detailed description
Respiratory failure is one of the most common conditions requiring admission to the pediatric intensive care unit (PICU). As such, chest radiography has emerged as the most commonly utilized tool in the assessment of lung pathology despite evidence that it may not be the most accurate. Since the seminal article by Lichtenstein in 2008, lung ultrasound has emerged as an alternative to chest radiography in the assessment of critically ill adults. Likewise, pediatric lung ultrasound has a growing body of research to support its use in commonly encountered lung pathology including pneumonia, asthma, bronchiolitis, acute chest syndrome, pleural effusions, and pneumothorax. Despite the rapidly growing body evidence, there remains little literature to support its use the diagnosis and management of acute respiratory failure in the PICU.
The proposed study will evaluate whether point-of-care lung ultrasound is accurate in determining the etiology of acute respiratory failure on admission to the PICU.
Specific aims include:
- Aim 1: To determine the sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU.
- Aim 2: To determine the inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers.
- Aim 3: Compare point-of-care lung ultrasound with chest radiography in the rate of detection of consolidation, interstitial edema, pneumothorax, and pleural effusion.
- Aim 4: Describe the POC-LUS findings in patients admitted to the PICU with acute respiratory failure
- Being tested
- Lung ultrasound, Clinical exam, Chest x-ray
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
A point-of-care lung ultrasound exam will be performed on admission (no later than 14 hours following admission, allowing for participant stabilization and care) to the PICU and within 6 hours of any escalation in mechanical ventilatory support without interrupting clinical care, by study investigators blinded to participant history, physical examination, and diagnostic testing/imaging and who are not involved in the clinical management of the participant. Investigators will use a six-zone standardized scanning protocol with pattern analysis to form a diagnosis for the cause of the participant's respiratory failure. Images will be acquired by pediatric critical care trainees and saved online; accuracy of diagnoses based on the ultrasound exam will be evaluated by a expert sonographer offline.
Clinical examDiagnostic test
Following morning ICU rounds, the PICU fellow or attending physician caring for the participant will be asked for his/her interpretation of the most recent chest radiograph and his/her diagnosis concerning the etiology of the participant's acute respiratory failure. This clinical diagnosis will be compared to ultrasound findings.
Chest x-rayDiagnostic test
Results of chest x-ray will be collected for comparison with ultrasound findings.
| Study group | Role | What they receive |
|---|---|---|
| Children with acute respiratory failure | Point-of-care lung ultrasound on admission to the PICU to determine the cause of respiratory failure. Receives: Diagnostic Test: Lung ultrasound; Diagnostic Test: Clinical exam; Diagnostic Test: Chest x-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU
The sensitivity of the lung ultrasound in identifying the etiology of acute pediatric respiratory failure will be determined by comparison with the final criterion or "gold standard" diagnosis generated by a blinded review of the chart after discharge by a study investigator blinded to the case. The hypothesis is that the lung ultrasound performed on admission to the PICU will have a sensitivity of > 90% in determining the etiology of acute respiratory failure in children (as determined by an independent review of the participant's medical record following hospital discharge).
Measured: up to one month
Specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU
The specificity of the lung ultrasound in identifying the etiology of acute pediatric respiratory failure will be determined by comparison with the final criterion or "gold standard" diagnosis generated by a blinded review of the chart after discharge by a study investigator blinded to the case. The hypothesis is that the lung ultrasound performed on admission to the PICU will have a specificity of > 90% in determining the etiology of acute respiratory failure in children (as determined by an independent review of the participant's medical record following hospital discharge).
Measured: up to one month
Secondary outcomes (1)
Inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers
Ultrasound images obtained by a critical care trainee will be saved online for review by an expert sonographer. The expert sonographer will overread the images; findings will be compared at all ultrasound points to determine percent agreement in interpreting ultrasound exam findings between the trainee and expert sonographer. Additionally final ultrasonographic diagnosis will be compared between trainee and expert sonographers. Interpretation of exam findings and determination of exam diagnosis will be compared to determine the inter-observer reliability of point-of-care lung ultrasound exams in acute pediatric respiratory failure. The hypothesis is that the inter-observer reliability between trainee and expert sonographers for point-of-care lung ultrasound findings will be >80%.
Measured: Following acquisition and interpretation of ultrasound images, an average of less than one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Dec 2018
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for Pediatric Respiratory DiseasesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Kory, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744169
- Sponsor's protocol ID
- 2018-0711
- Other IDs
- A534285, SMPH/MEDICINE/PULMON MED, Protocol Version 4/7/2020
- Status last verified
- Jun 2020
- First submitted
- 8 Nov 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Namachivayam P, Shann F, Shekerdemian L, Taylor A, van Sloten I, Delzoppo C, Daffey C, Butt W. Three decades of pediatric intensive care: Who was admitted, what happened in intensive care, and what happened afterward. Pediatr Crit Care Med. 2010 Sep;11(5):549-55. doi: 10.1097/PCC.0b013e3181ce7427.
PubMed 20124947Krmpotic K, Lobos AT. Clinical profile of children requiring early unplanned admission to the PICU. Hosp Pediatr. 2013 Jul;3(3):212-8. doi: 10.1542/hpeds.2012-0081.
PubMed 24313089Gurney JW. Why chest radiography became routine. Radiology. 1995 Apr;195(1):245-6. doi: 10.1148/radiology.195.1.7892479. No abstract available.
PubMed 7892479Price MB, Grant MJ, Welkie K. Financial impact of elimination of routine chest radiographs in a pediatric intensive care unit. Crit Care Med. 1999 Aug;27(8):1588-93. doi: 10.1097/00003246-199908000-00033.
PubMed 10470769Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.
PubMed 14695718Self WH, Courtney DM, McNaughton CD, Wunderink RG, Kline JA. High discordance of chest x-ray and computed tomography for detection of pulmonary opacities in ED patients: implications for diagnosing pneumonia. Am J Emerg Med. 2013 Feb;31(2):401-5. doi: 10.1016/j.ajem.2012.08.041. Epub 2012 Oct 18.
PubMed 23083885Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
PubMed 18403664Peris A, Tutino L, Zagli G, Batacchi S, Cianchi G, Spina R, Bonizzoli M, Migliaccio L, Perretta L, Bartolini M, Ban K, Balik M. The use of point-of-care bedside lung ultrasound significantly reduces the number of radiographs and computed tomography scans in critically ill patients. Anesth Analg. 2010 Sep;111(3):687-92. doi: 10.1213/ANE.0b013e3181e7cc42.
PubMed 20733164Zieleskiewicz L, Cornesse A, Hammad E, Haddam M, Brun C, Vigne C, Meyssignac B, Remacle A, Chaumoitre K, Antonini F, Martin C, Leone M. Implementation of lung ultrasound in polyvalent intensive care unit: Impact on irradiation and medical cost. Anaesth Crit Care Pain Med. 2015 Feb;34(1):41-4. doi: 10.1016/j.accpm.2015.01.002. Epub 2015 Mar 5.
PubMed 25829314Oks M, Cleven KL, Cardenas-Garcia J, Schaub JA, Koenig S, Cohen RI, Mayo PH, Narasimhan M. The effect of point-of-care ultrasonography on imaging studies in the medical ICU: a comparative study. Chest. 2014 Dec;146(6):1574-1577. doi: 10.1378/chest.14-0728.
PubMed 25144593Inglis AJ, Nalos M, Sue KH, Hruby J, Campbell DM, Braham RM, Orde SR. Bedside lung ultrasound, mobile radiography and physical examination: a comparative analysis of diagnostic tools in the critically ill. Crit Care Resusc. 2016 Jun;18(2):124.
PubMed 27242110Expert Round Table on Ultrasound in ICU. International expert statement on training standards for critical care ultrasonography. Intensive Care Med. 2011 Jul;37(7):1077-83. doi: 10.1007/s00134-011-2246-9. Epub 2011 May 26.
PubMed 21614639Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
PubMed 22392031Frankel HL, Kirkpatrick AW, Elbarbary M, Blaivas M, Desai H, Evans D, Summerfield DT, Slonim A, Breitkreutz R, Price S, Marik PE, Talmor D, Levitov A. Guidelines for the Appropriate Use of Bedside General and Cardiac Ultrasonography in the Evaluation of Critically Ill Patients-Part I: General Ultrasonography. Crit Care Med. 2015 Nov;43(11):2479-502. doi: 10.1097/CCM.0000000000001216.
PubMed 26468699Levitov A, Frankel HL, Blaivas M, Kirkpatrick AW, Su E, Evans D, Summerfield DT, Slonim A, Breitkreutz R, Price S, McLaughlin M, Marik PE, Elbarbary M. Guidelines for the Appropriate Use of Bedside General and Cardiac Ultrasonography in the Evaluation of Critically Ill Patients-Part II: Cardiac Ultrasonography. Crit Care Med. 2016 Jun;44(6):1206-27. doi: 10.1097/CCM.0000000000001847.
PubMed 27182849
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Point-of-care Lung Ultrasound to Diagnose the Etiology of Acute Respiratory Failure in a Pediatric Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03744169
- Acronym / sponsor ID
- 2018-0711
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 16 Nov 2018 (actual)
- 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 is to determine the utility of point-of-care lung ultrasound (POC-LUS) in identifying the etiology of acute respiratory failure in pediatric patients admitted to the pediatric intensive care unit.
Detailed description
Respiratory failure is one of the most common conditions requiring admission to the pediatric intensive care unit (PICU). As such, chest radiography has emerged as the most commonly utilized tool in the assessment of lung pathology despite evidence that it may not be the most accurate. Since the seminal article by Lichtenstein in 2008, lung ultrasound has emerged as an alternative to chest radiography in the assessment of critically ill adults. Likewise, pediatric lung ultrasound has a growing body of research to support its use in commonly encountered lung pathology including pneumonia, asthma, bronchiolitis, acute chest syndrome, pleural effusions, and pneumothorax. Despite the rapidly growing body evidence, there remains little literature to support its use the diagnosis and management of acute respiratory failure in the PICU.
The proposed study will evaluate whether point-of-care lung ultrasound is accurate in determining the etiology of acute respiratory failure on admission to the PICU.
Specific aims include:
- Aim 1: To determine the sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU.
- Aim 2: To determine the inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers.
- Aim 3: Compare point-of-care lung ultrasound with chest radiography in the rate of detection of consolidation, interstitial edema, pneumothorax, and pleural effusion.
- Aim 4: Describe the POC-LUS findings in patients admitted to the PICU with acute respiratory failure
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with acute respiratory failure | – | Diagnostic Test: Lung ultrasound, Diagnostic Test: Clinical exam, Diagnostic Test: Chest x-rayPoint-of-care lung ultrasound on admission to the PICU to determine the cause of respiratory failure. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients age greater than 37 weeks gestational age and less than 18 years old with a clinical diagnosis of acute respiratory failure and the need for non-invasive (HFNC > 1 L/kg/min, CPAP, or BiPAP) or invasive mechanical ventilation.
Key inclusion criteria (4 listed)
- Age greater than 37 weeks gestational age and less than 18 years
- Admitted to PICU
- Clinical diagnosis of acute respiratory failure
- Requirement of non-invasive or invasive respiratory support (as defined by a clinical need for high flow nasal cannula >1L/kg/min; RAM cannula, nasal or full face mask delivered continuous positive airway pressure ventilation; RAM cannula, nasal or full face mask delivered bi-level positive airway pressure ventilation; or invasive mechanical ventilation); requirement of supplemental oxygen with FiO2 > 0.35 while on high flow nasal cannula <1L/kg/min to maintain saturations > 90%; continuous nebulized therapy; or chronic use of home oxygen or ventilator support AND any increase in home settings
Key exclusion criteria (2 listed)
- Hemodynamically unstable as defined by the initiation of or the need for increased vasopressor support within the previous 30 minutes
- Known chronic respiratory disease such as primary ciliary dyskinesia, cystic fibrosis, or congenital pulmonary malformations.
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 |
|---|---|---|
| Lung ultrasoundA point-of-care lung ultrasound exam will be performed on admission (no later than 14 hours following admission, allowing for participant stabilization and care) to the PICU and within 6 hours of any escalation in mechanical ventilatory support without interrupting clinical care, by study investigators blinded to participant history, physical examination, and diagnostic testing/imaging and who are not involved in the clinical management of the participant. Investigators will use a six-zone standardized scanning protocol with pattern analysis to form a diagnosis for the cause of the participant's respiratory failure. Images will be acquired by pediatric critical care trainees and saved online; accuracy of diagnoses based on the ultrasound exam will be evaluated by a expert sonographer offline. | Diagnostic test | Children with acute respiratory failure |
| Clinical examFollowing morning ICU rounds, the PICU fellow or attending physician caring for the participant will be asked for his/her interpretation of the most recent chest radiograph and his/her diagnosis concerning the etiology of the participant's acute respiratory failure. This clinical diagnosis will be compared to ultrasound findings. | Diagnostic test | Children with acute respiratory failure |
| Chest x-rayResults of chest x-ray will be collected for comparison with ultrasound findings. | Diagnostic test | Children with acute respiratory failure |
Primary outcome
Sensitivity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU
Time frame: up to one month
The sensitivity of the lung ultrasound in identifying the etiology of acute pediatric respiratory failure will be determined by comparison with the final criterion or "gold standard" diagnosis generated by a blinded review of the chart after discharge by a study investigator blinded to the case. The hypothesis is that the lung ultrasound performed on admission to the PICU will have a sensitivity of > 90% in determining the etiology of acute respiratory failure in children (as determined by an independent review of the participant's medical record following hospital discharge).
Specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU
Time frame: up to one month
The specificity of the lung ultrasound in identifying the etiology of acute pediatric respiratory failure will be determined by comparison with the final criterion or "gold standard" diagnosis generated by a blinded review of the chart after discharge by a study investigator blinded to the case. The hypothesis is that the lung ultrasound performed on admission to the PICU will have a specificity of > 90% in determining the etiology of acute respiratory failure in children (as determined by an independent review of the participant's medical record following hospital discharge).
1 secondary outcome
Inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers
Time frame: Following acquisition and interpretation of ultrasound images, an average of less than one week
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 23 Jun 2020.
- Background: PubMed 20124947Namachivayam P, Shann F, Shekerdemian L, Taylor A, van Sloten I, Delzoppo C, Daffey C, Butt W. Three decades of pediatric intensive care: Who was admitted, what happened in intensive care, and what happened afterward. Pediatr Crit Care Med. 2010 Sep;11(5):549-55. doi: 10.1097/PCC.0b013e3181ce7427.
- Background: PubMed 24313089Krmpotic K, Lobos AT. Clinical profile of children requiring early unplanned admission to the PICU. Hosp Pediatr. 2013 Jul;3(3):212-8. doi: 10.1542/hpeds.2012-0081.
- Background: PubMed 7892479Gurney JW. Why chest radiography became routine. Radiology. 1995 Apr;195(1):245-6. doi: 10.1148/radiology.195.1.7892479. No abstract available.
- Background: PubMed 10470769Price MB, Grant MJ, Welkie K. Financial impact of elimination of routine chest radiographs in a pediatric intensive care unit. Crit Care Med. 1999 Aug;27(8):1588-93. doi: 10.1097/00003246-199908000-00033.
- Background: PubMed 14695718Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.
- Background: PubMed 23083885Self WH, Courtney DM, McNaughton CD, Wunderink RG, Kline JA. High discordance of chest x-ray and computed tomography for detection of pulmonary opacities in ED patients: implications for diagnosing pneumonia. Am J Emerg Med. 2013 Feb;31(2):401-5. doi: 10.1016/j.ajem.2012.08.041. Epub 2012 Oct 18.
- Background: PubMed 18403664Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
- Background: PubMed 20733164Peris A, Tutino L, Zagli G, Batacchi S, Cianchi G, Spina R, Bonizzoli M, Migliaccio L, Perretta L, Bartolini M, Ban K, Balik M. The use of point-of-care bedside lung ultrasound significantly reduces the number of radiographs and computed tomography scans in critically ill patients. Anesth Analg. 2010 Sep;111(3):687-92. doi: 10.1213/ANE.0b013e3181e7cc42.
- Background: PubMed 25829314Zieleskiewicz L, Cornesse A, Hammad E, Haddam M, Brun C, Vigne C, Meyssignac B, Remacle A, Chaumoitre K, Antonini F, Martin C, Leone M. Implementation of lung ultrasound in polyvalent intensive care unit: Impact on irradiation and medical cost. Anaesth Crit Care Pain Med. 2015 Feb;34(1):41-4. doi: 10.1016/j.accpm.2015.01.002. Epub 2015 Mar 5.
- Background: PubMed 25144593Oks M, Cleven KL, Cardenas-Garcia J, Schaub JA, Koenig S, Cohen RI, Mayo PH, Narasimhan M. The effect of point-of-care ultrasonography on imaging studies in the medical ICU: a comparative study. Chest. 2014 Dec;146(6):1574-1577. doi: 10.1378/chest.14-0728.
- Background: PubMed 27242110Inglis AJ, Nalos M, Sue KH, Hruby J, Campbell DM, Braham RM, Orde SR. Bedside lung ultrasound, mobile radiography and physical examination: a comparative analysis of diagnostic tools in the critically ill. Crit Care Resusc. 2016 Jun;18(2):124.
- Background: PubMed 21614639Expert Round Table on Ultrasound in ICU. International expert statement on training standards for critical care ultrasonography. Intensive Care Med. 2011 Jul;37(7):1077-83. doi: 10.1007/s00134-011-2246-9. Epub 2011 May 26.
- Individual participant dataSharing planned: No
Related trials for Pediatric Respiratory Diseases
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Not yet recruiting
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Pediatric Pneumonia
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
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.
Pierre Kory, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Respiratory Diseases and Respiratory Failure, run by University of Wisconsin, Madison at 1 site in United States.
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 4 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 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Sensitivity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU (time frame: up to one month). The study lists 2 primary outcomes in all. 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 NCT03744169, which also lists 62 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 23 Jun 2020.