NCT04328220

Brief Summary

The use of POCUS in pediatrics is gaining momentum, and whilst pediatric specific data remains limited when compared to adult critical care, there is growing pediatric evidence demonstrating the high sensitivity and specificity of lung POCUS in the diagnosis of pneumonia, bronchiolitis, pleural effusion and pneumothorax. the American Academy of Pediatrics policy statement cautions that "clinicians should be aware that point of care ultrasonography is better used as a rule in and not a rule out diagnostic modality".

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

March 28, 2020

Last Update Submit

April 3, 2020

Conditions

Pediatric Respiratory Diseases

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of respiratory distress among patients admitted to the PICU.

    The sensitivity and specificity of the lung ultrasound in identifying the etiology of respiratory distress will be determined by comparison with bedside chest x ray.

    baseline

Interventions

chest ultrasoundDIAGNOSTIC_TEST

A point-of-care lung ultrasound exam will be performed within 24h of admission to PICU and serial follow up according to each case. chest x-ray will be performed for comparison with ultrasound findings.

Also known as: Chest x-ray

Eligibility Criteria

Age1 Month - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsup to 18 Years
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients age 1 month and less than 18 years old with a clinical diagnosis of acute respiratory distress admitted in PICU Assiut University Children Hospital either connected to mechanical ventilation or not.

You may qualify if:

  • Age \>1month \& \<18years old
  • All cases with clinically respiratory distress admitted in PICU Assiut University Children Hospital either connected to mechanical ventilation or not.

You may not qualify if:

  • Neonate.
  • Congenital anomalies of respiratory tract.
  • Cardiac diseases either congenital or acquired.
  • Traumatic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Quercia M, Panza R, Calderoni G, Di Mauro A, Laforgia N. Lung Ultrasound: A New Tool in the Management of Congenital Lung Malformation. Am J Perinatol. 2019 Jul;36(S 02):S99-S105. doi: 10.1055/s-0039-1692131. Epub 2019 Jun 25.

    PMID: 31238368BACKGROUND

  • Supakul N, Karmazyn B. Ultrasound of the pediatric chest--the ins and outs. Semin Ultrasound CT MR. 2013 Jun;34(3):274-85. doi: 10.1053/j.sult.2012.12.001.

    PMID: 23768893BACKGROUND

  • Volpicelli 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.

    PMID: 22392031BACKGROUND

  • Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.

    PMID: 17316468BACKGROUND

  • Basile V, Di Mauro A, Scalini E, Comes P, Lofu I, Mostert M, Tafuri S, Manzionna MM. Lung ultrasound: a useful tool in diagnosis and management of bronchiolitis. BMC Pediatr. 2015 May 21;15:63. doi: 10.1186/s12887-015-0380-1.

    PMID: 25993984BACKGROUND

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Zeinab Mohey Eldeen, Professor

CONTACT

01028868829Zeinabmohieldeen1957@gmail.com

Duaa Rafaat, Assistant Prof

CONTACT

01223112124duaa_raafat@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principlal investigator

Study Record Dates

First Submitted

March 28, 2020

First Posted

March 31, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

April 7, 2020

Record last verified: 2020-04