Can the Thoracic Replace the Conventional Radiography for... | NCT02781363

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

NCT02781363

Sponsor

Hospital Universitari General de Catalunya

Status

Withdrawn

Last Update Posted

Aug 11, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Pneumonia

Interventions

Thoracic ultrasound
CXR

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The principal investigator left the center in 2016.

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Apr 30, 2016Actual

Completion Date

Jun 1, 2016Actual

First Submitted Date

May 18, 2016

First Submission Date that Met QC Criteria

May 23, 2016

First Posted Date

May 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2022

Last Update Posted Date

Aug 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Montse Granados, Hospital Universitari General de Catalunya, Hospital Universitari General de CatalunyaPrincipal Investigator

Lead Sponsor

Hospital Universitari General de CatalunyaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Candidates patients chest X-ray with pneumonia	Other	thoracic sonography CXR Clinical control 48h	Other: Thoracic ultrasound Other: CXR
Candidates patients chest X-ray without pneumonia	Other	thoracic sonography CXR Clinical control 48h	Other: Thoracic ultrasound Other: CXR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracic ultrasound	Other		Candidates patients chest X-ray with pneumonia Candidates patients chest X-ray without pneumonia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
coincidence between the ultrasound image and conventional radiography	images compatible with pneumonic consolidations in sonography and radiography . Coincidence between evaluators	1 day

Secondary Outcomes

Measure	Description	Time Frame
additional workload	Time (minutes) between the test requested and the results are obtained for both diagnostic tests	1 day

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital UNiversitari General de Catalunya		Sant Cugat del Vallès	Catalonia	08195	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided