Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?

• Sponsor: Hospital Universitari General de Catalunya (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02781363
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The Thoracic ultrasound is a safer and sensitive technique than conventional radiography because it detects less than 1 cm pneumonic consolidations and minimal pleural effusions. The main objective is to evaluate the efficacy of thoracic ultrasound performed by unskilled personnel in the emergency service prdiatricas to diagnose pneumonia in children.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Other: Thoracic ultrasound; Other: CXR	N/A

Detailed Description

Diagnostic test evaluation.The sample collected sequentially until an exact size . Given the safety of the technique, which involves no risk to patient management and the possibility of generating a type II error by premature study discontinuation , we have no plans to make any interim analyzes .

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Apr 30, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Candidates patients chest X-ray with pneumonia thoracic sonography CXR Clinical control 48h	Other: Thoracic ultrasound; Other: CXR
Other: Candidates patients chest X-ray without pneumonia thoracic sonography CXR Clinical control 48h	Other: Thoracic ultrasound; Other: CXR

Outcome Measures

Primary Outcome Measures

1. coincidence between the ultrasound image and conventional radiography [1 day]

   images compatible with pneumonic consolidations in sonography and radiography . Coincidence between evaluators

Secondary Outcome Measures

1. additional workload [1 day]

   Time (minutes) between the test requested and the results are obtained for both diagnostic tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• fever above 38 degrees

• tachypnea

• Difficulty breathing

• Side tip pain

• pathological auscultation

Exclusion Criteria:

• < 3 months> 14 years

• Background of Prematurity

• Rewalizados imaging studies in the last 7 days

• Any chronic respiratory process

• congenital heart diseases

• hemodynamic instability

• Diagnosis of pneumonia in the last 3 months

• Refusal of relatives to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital UNiversitari General de Catalunya	Sant Cugat del Vallès	Catalonia	Spain	08195

Sponsors and Collaborators

• Hospital Universitari General de Catalunya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montse Granados, Hospital Universitari General de Catalunya, Hospital Universitari General de Catalunya
• ClinicalTrials.gov Identifier: NCT02781363
• Other Study ID Numbers: 2015/51-PED-HGC
• First Posted: May 24, 2016
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Montse Granados, Hospital Universitari General de Catalunya, Hospital Universitari General de Catalunya: thoracic ultrasound; children; efficacy; emergency service
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Aug 11, 2022