NCT02925936

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

May 12, 2016

Last Update Submit

October 4, 2016

Conditions

Keywords

RadiographyRadiationDiagnostic imaging

Outcome Measures

Primary Outcomes (1)

  • Dose of radiation used in thyroid gland with Ionization chamber

    Assessed using ionization chamber

    One month

Secondary Outcomes (2)

  • Dose of radiation used in thorax with spectrometer

    One month

  • Dose of radiation used in gonads with tape to measure

    One month

Study Arms (2)

Cathode

ACTIVE COMPARATOR

Thyroid facing the cathode end of xray machine

Other: Thyroid facing the cathode end of xray machine

Anode

ACTIVE COMPARATOR

Thyroid facing the anode end of xray machine

Other: Thyroid facing the anode end of xray machine

Interventions

Thyroid position: facing the anode end of xray machine

Anode

Thyroid position: facing the cathode end of xray machine

Cathode

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Younger than 12 years old
  • Admitted to the Paediatric ICU at Instituto de Cardiologia de Porto Alegre
  • Chest X ray requested by treating physician

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

Related Publications (2)

  • 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.

  • Rodrigues 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.

Study Officials

  • Silvia Goldmeier, Dr

    Instituto de Cardiologia do Rio Grande do Sul

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

May 12, 2016

First Posted

October 6, 2016

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations