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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04328220
Other study ID # chest US in PICU
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date October 1, 2021

Study information

Verified date April 2020
Source Assiut University
Contact Zeinab Mohey Eldeen, Professor
Phone 01028868829
Email Zeinabmohieldeen1957@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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".


Description:

In recent years, the use of point-of-care ultrasound (PoCUS), understood as the bedside ultrasound examination of the patient by the physician in charge, has been increasing in paediatric patients for the investigation of pulmonary, pleural and diaphragmatic disease, following its use in adult patients, in whom the technique has been developing for more than a decade, and whose ultrasound semiotics can be safely extrapolated to the paediatric age group. The unossified costal cartilage and sternum and thinner adipose subcutaneous tissue in children provide ideal acoustic windows.

This study aims to compare the use of bedside lung US to portable chest X-ray regarding sensitivity, specificity, safety and accuracy in identifying the etiology of respiratory distress among children admitted to the PICU.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

- Age >1month & <18years old

- All cases with clinically respiratory distress admitted in PICU Assiut University Children Hospital either connected to mechanical ventilation or not.

Exclusion Criteria:

1. Neonate.

2. Congenital anomalies of respiratory tract.

3. Cardiac diseases either congenital or acquired.

4. Traumatic patients.

Study Design


Intervention

Diagnostic Test:
chest ultrasound
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Basile V, Di Mauro A, Scalini E, Comes P, Lofù 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. — View Citation

Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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