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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02925936
Other study ID # 4769/12
Secondary ID
Status Completed
Phase N/A
First received May 12, 2016
Last updated October 4, 2016
Start date June 2014
Est. completion date July 2015

Study information

Verified date October 2016
Source Instituto de Cardiologia do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the position of the anode and cathode.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Years
Eligibility Inclusion Criteria:

- Younger than 12 years old

- Admitted to the Paediatric ICU at Instituto de Cardiologia de Porto Alegre

- Chest X ray requested by treating physician

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Thyroid facing the anode end of xray machine
Thyroid position: facing the anode end of xray machine
Thyroid facing the cathode end of xray machine
Thyroid position: facing the cathode end of xray machine

Locations

Country Name City State
Brazil Instituto de Cardiologia do Rio Grande do Sul Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose of radiation used in thyroid gland with Ionization chamber Assessed using ionization chamber One month Yes
Secondary Dose of radiation used in thorax with spectrometer Assessed using ionization chamber One month Yes
Secondary Dose of radiation used in gonads with tape to measure Assessed using ionization chamber One month Yes
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