PneumoniaNCT02781363
Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
A study testing Thoracic ultrasound and CXR in people with Pneumonia, run by Hospital Universitari General de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Thoracic ultrasound and CXR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 1 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- fever above 38 degrees
- tachypnea
- Difficulty breathing
- Side tip pain
- pathological auscultation
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital UNiversitari General de Catalunya
Sant Cugat del Vallès, Catalonia, 08195
About this study
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.
Read the 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 .
- Conditions
- Pneumonia
- Being tested
- Thoracic ultrasound, CXR
- Keywords
- thoracic ultrasound, children, efficacy, emergency service
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic ultrasoundOther
CXROther
| Study group | Role | What they receive |
|---|---|---|
| Candidates patients chest X-ray with pneumonia | Other | thoracic sonography CXR Clinical control 48h Receives: Other: Thoracic ultrasound; Other: CXR |
| Candidates patients chest X-ray without pneumonia | Other | thoracic sonography CXR Clinical control 48h Receives: Other: Thoracic ultrasound; Other: CXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
coincidence between the ultrasound image and conventional radiography
images compatible with pneumonic consolidations in sonography and radiography . Coincidence between evaluators
Measured: 1 day
Secondary outcomes (1)
additional workload
Time (minutes) between the test requested and the results are obtained for both diagnostic tests
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start1 Jan 2016
- Primary completion30 Apr 2016
- Study completion1 Jun 2016
Why it stopped: The principal investigator left the center in 2016.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari General de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montse Granados, Hospital Universitari General de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781363
- Sponsor's protocol ID
- 2015/51-PED-HGC
- Status last verified
- Aug 2022
- First submitted
- 18 May 2016
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
- ClinicalTrials.gov ID
- NCT02781363
- Acronym / sponsor ID
- 2015/51-PED-HGC
- Conditions
- Pneumonia
- Keywords
- thoracic ultrasound, children, efficacy, emergency service
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The principal investigator left the center in 2016.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitari General de CatalunyaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candidates patients chest X-ray with pneumonia | Other | Other: Thoracic ultrasound, Other: CXRthoracic sonography CXR Clinical control 48h |
| Candidates patients chest X-ray without pneumonia | Other | Other: Thoracic ultrasound, Other: CXRthoracic sonography CXR Clinical control 48h |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- fever above 38 degrees
- tachypnea
- Difficulty breathing
- Side tip pain
- pathological auscultation
Key exclusion criteria (8 listed)
- < 3 months> 14 years
- Background of Prematurity
- Rewalizados imaging studies in the last 7 days
- Any chronic respiratory process
- congenital heart diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic ultrasound | Other | Candidates patients chest X-ray with pneumonia, Candidates patients chest X-ray without pneumonia |
| CXR | Other | Candidates patients chest X-ray with pneumonia, Candidates patients chest X-ray without pneumonia |
Primary outcome
coincidence between the ultrasound image and conventional radiography
Time frame: 1 day
images compatible with pneumonic consolidations in sonography and radiography . Coincidence between evaluators
1 secondary outcome
additional workload
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic ultrasound and CXR in people with Pneumonia, run by Hospital Universitari General de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coincidence between the ultrasound image and conventional radiography (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.