Diagnostic Role of Chest Ultrasound in Children Presenting With Respiratory Distress in Pediatric Intensive Care Unit (PICU) Compared to Chest X-ray (PICU)

April 3, 2020 updated by: Mahmoud Kotb, Assiut University

Diagnostic Role of Chest Ultrasound in Children Presenting With Respiratory Distress in PICU Compared to Chest X-ray

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".

Study Overview

Status

Unknown

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of respiratory distress among patients admitted to the PICU.
Time Frame: baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

March 28, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chest US in PICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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