Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
Primary Purpose
Pneumonia
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Thoracic ultrasound
CXR
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia focused on measuring thoracic ultrasound, children, efficacy, emergency service
Eligibility Criteria
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
Sites / Locations
- Hospital UNiversitari General de Catalunya
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Candidates patients chest X-ray with pneumonia
Candidates patients chest X-ray without pneumonia
Arm Description
thoracic sonography CXR Clinical control 48h
thoracic sonography CXR Clinical control 48h
Outcomes
Primary Outcome Measures
coincidence between the ultrasound image and conventional radiography
images compatible with pneumonic consolidations in sonography and radiography . Coincidence between evaluators
Secondary Outcome Measures
additional workload
Time (minutes) between the test requested and the results are obtained for both diagnostic tests
Full Information
NCT ID
NCT02781363
First Posted
May 18, 2016
Last Updated
August 9, 2022
Sponsor
Hospital Universitari General de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT02781363
Brief Title
Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
Official Title
Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The principal investigator left the center in 2016.
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari General de Catalunya
4. Oversight
Data Monitoring Committee
No
5. 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
thoracic ultrasound, children, efficacy, emergency service
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Candidates patients chest X-ray with pneumonia
Arm Type
Other
Arm Description
thoracic sonography CXR Clinical control 48h
Arm Title
Candidates patients chest X-ray without pneumonia
Arm Type
Other
Arm Description
thoracic sonography CXR Clinical control 48h
Intervention Type
Other
Intervention Name(s)
Thoracic ultrasound
Intervention Type
Other
Intervention Name(s)
CXR
Primary Outcome Measure Information:
Title
coincidence between the ultrasound image and conventional radiography
Description
images compatible with pneumonic consolidations in sonography and radiography . Coincidence between evaluators
Time Frame
1 day
Secondary Outcome Measure Information:
Title
additional workload
Description
Time (minutes) between the test requested and the results are obtained for both diagnostic tests
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital UNiversitari General de Catalunya
City
Sant Cugat del Vallès
State/Province
Catalonia
ZIP/Postal Code
08195
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
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