Radiation AbsorptionNCT02925936
Choice of Tube Extremity in Emission of Lowest Radiation Dose in Pediatric Patients
A study testing Thyroid facing the anode end of xray machine and Thyroid facing the cathode end of xray machine in people with Radiation Absorption and Radiography, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the position of the anode and cathode. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Radiation Absorption, Radiography
- What is being tested?
- Thyroid facing the anode end of xray machine and Thyroid facing the cathode end of xray machine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Jul 2015
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Younger than 12 years old
- Admitted to the Paediatric ICU at Instituto de Cardiologia de Porto Alegre
- Chest X ray requested by treating physician
Who cannot join
- Patients with scans that failed to comply with the technical criteria from the European Community Commission guidelines on quality criteria for diagnostic radiographic images in paediatrics, as evaluated by the radiologist doctors responsible for that exam report.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-000
About this study
Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the position of the anode and cathode.
Read the detailed description
The study's primary goal was to compare radiation exposure in two different positions during chest x rays in children. It was conducted from June/2014 to July/2015, and included children from 0 to12 years old staying at the Pediatric Intensive Care Unit at the Instituto de Cardiologia de Porto Alegre, Brazil, with chest x ray requests during ICU stay. They were randomized to two groups: during the x ray, one group was positioned with the thyroid facing the anode end, and the other group was positioned with the thyroid facing the cathode end.
- Conditions
- Radiation Absorption, Radiography
- Being tested
- Thyroid facing the anode end of xray machine, Thyroid facing the cathode end of xray machine
- Keywords
- Radiography, Radiation, Diagnostic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid facing the anode end of xray machineOther
Thyroid position: facing the anode end of xray machine
Thyroid facing the cathode end of xray machineOther
Thyroid position: facing the cathode end of xray machine
| Study group | Role | What they receive |
|---|---|---|
| Cathode | Active comparator | Thyroid facing the cathode end of xray machine Receives: Other: Thyroid facing the cathode end of xray machine |
| Anode | Active comparator | Thyroid facing the anode end of xray machine Receives: Other: Thyroid facing the anode end of xray machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of radiation used in thyroid gland with Ionization chamber
Assessed using ionization chamber
Measured: One month
Secondary outcomes (2)
Dose of radiation used in thorax with spectrometer
Assessed using ionization chamber
Measured: One month
Dose of radiation used in gonads with tape to measure
Assessed using ionization chamber
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiation AbsorptionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Oberto Rodrigues, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Silvia Goldmeier, Dr, Study chair, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925936
- Sponsor's protocol ID
- 4769/12
- Status last verified
- Oct 2016
- First submitted
- 12 May 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Daruich De Souza C, Rico Freitas G, Fachel Medeiros R, Ramalho E, Rodrigues SC, Oberto Rodrigues G. Protocol for reducing radiation exposure during pediatric thoracic radiography. J Med Imaging Radiat Sci. 2022 Sep;53(3):437-443. doi: 10.1016/j.jmir.2022.05.012. Epub 2022 Jun 21.
PubMed 35750602Rodrigues GO, Medeiros RF, Rodrigues SC, Boll LFC, Irigoyen MC, Goldmeier S. Choice of tube extremity for emission of the lowest radiation dose in pediatric patients. Int J Cardiol Heart Vasc. 2018 Oct 10;21:64-68. doi: 10.1016/j.ijcha.2018.06.006. eCollection 2018 Dec.
PubMed 30320204
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Tube Extremity in Emission of Lowest Radiation Dose in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02925936
- Acronym / sponsor ID
- 4769/12
- Conditions
- Radiation Absorption, Radiography
- Keywords
- Radiography, Radiation, Diagnostic imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Oct 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.
Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the position of the anode and cathode.
Detailed description
The study's primary goal was to compare radiation exposure in two different positions during chest x rays in children. It was conducted from June/2014 to July/2015, and included children from 0 to12 years old staying at the Pediatric Intensive Care Unit at the Instituto de Cardiologia de Porto Alegre, Brazil, with chest x ray requests during ICU stay. They were randomized to two groups: during the x ray, one group was positioned with the thyroid facing the anode end, and the other group was positioned with the thyroid facing the cathode end.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cathode | Active comparator | Other: Thyroid facing the cathode end of xray machineThyroid facing the cathode end of xray machine |
| Anode | Active comparator | Other: Thyroid facing the anode end of xray machineThyroid facing the anode end of xray machine |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Younger than 12 years old
- Admitted to the Paediatric ICU at Instituto de Cardiologia de Porto Alegre
- Chest X ray requested by treating physician
Key exclusion criteria (1 listed)
- Patients with scans that failed to comply with the technical criteria from the European Community Commission guidelines on quality criteria for diagnostic radiographic images in paediatrics, as evaluated by the radiologist doctors responsible for that exam report.
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 |
|---|---|---|
| Thyroid facing the anode end of xray machineThyroid position: facing the anode end of xray machine | Other | Anode |
| Thyroid facing the cathode end of xray machineThyroid position: facing the cathode end of xray machine | Other | Cathode |
Primary outcome
Dose of radiation used in thyroid gland with Ionization chamber
Time frame: One month
Assessed using ionization chamber
2 secondary outcomes
Dose of radiation used in thorax with spectrometer
Time frame: One month
Dose of radiation used in gonads with tape to measure
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Derived from this study: PubMed 35750602Daruich De Souza C, Rico Freitas G, Fachel Medeiros R, Ramalho E, Rodrigues SC, Oberto Rodrigues G. Protocol for reducing radiation exposure during pediatric thoracic radiography. J Med Imaging Radiat Sci. 2022 Sep;53(3):437-443. doi: 10.1016/j.jmir.2022.05.012. Epub 2022 Jun 21.
- Derived from this study: PubMed 30320204Rodrigues GO, Medeiros RF, Rodrigues SC, Boll LFC, Irigoyen MC, Goldmeier S. Choice of tube extremity for emission of the lowest radiation dose in pediatric patients. Int J Cardiol Heart Vasc. 2018 Oct 10;21:64-68. doi: 10.1016/j.ijcha.2018.06.006. eCollection 2018 Dec.
- 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.
Silvia Goldmeier, Dr study chair
Instituto de Cardiologia do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid facing the anode end of xray machine and Thyroid facing the cathode end of xray machine in people with Radiation Absorption and Radiography, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2016. 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose of radiation used in thyroid gland with Ionization chamber (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925936, which also lists 2 linked publications.
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 6 Oct 2016.