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Completed

NCT Number: NCT02622269

Patient-driven Compression in Urography

Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.

Evaluation of radiation dose, image quality and patients' experiences

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Key information

Conditions

Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiology

Örebro, 70185, Sweden

About this study

Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.

Two compression devices are investigated in each patient, in randomized order.

Aims of the study:

  • Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.
  • Evaluate image quality with the two devices.
  • Describe patients' experiences from using the two devices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients with a request for a urographic study

Exclusion criteria

  • Emergency studies,
  • cannot participate actively with compression,
  • contraindications to compression of the abdomen,
  • pregnancy,
  • inability to understand the language of the questionnaire

Treatment and study plan

Patient-regulated compression device

Device

Compression of the abdomen with a patient-regulated compression device

Standard compression device

Device

Compression of the abdomen with the standard compression device

Primary outcomes

  1. Radiation dose measured as Dose-area product

    Time frame: Immediately

    Radiation dose for the investigated exposures, measured as Dose-area product

Secondary outcomes

  1. Image quality measured with Visual Grading

    Time frame: Immediately

    Image quality for the investigated images, measured with Visual Grading

  2. Patient experience (questionnaire)

    Time frame: Immediately after the procedure

    A questionnaire will be analysed with qualitative content analysis

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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