NCT02781363

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

May 18, 2016

Last Update Submit

August 9, 2022

Conditions

Pneumonia

Keywords

thoracic ultrasoundchildrenefficacyemergency service

Outcome Measures

Primary Outcomes (1)

  • coincidence between the ultrasound image and conventional radiography

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

    1 day

Secondary Outcomes (1)

  • additional workload

    1 day

Study Arms (2)

Candidates patients chest X-ray with pneumonia

OTHER

thoracic sonography CXR Clinical control 48h

Other: Thoracic ultrasoundOther: CXR

Candidates patients chest X-ray without pneumonia

OTHER

thoracic sonography CXR Clinical control 48h

Other: Thoracic ultrasoundOther: CXR

Interventions

Thoracic ultrasoundOTHER
Candidates patients chest X-ray with pneumoniaCandidates patients chest X-ray without pneumonia
CXROTHER
Candidates patients chest X-ray with pneumoniaCandidates patients chest X-ray without pneumonia

Eligibility Criteria

Age3 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • fever above 38 degrees
  • tachypnea
  • Difficulty breathing
  • Side tip pain
  • pathological auscultation

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital UNiversitari General de Catalunya

Sant Cugat del Vallès, Catalonia, 08195, Spain

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital Universitari General de Catalunya

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 24, 2016

Study Start

January 1, 2016

Primary Completion

April 30, 2016

Study Completion

June 1, 2016

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)