Patient-driven Compression in Urography

February 24, 2016 updated by: Håkan Geijer, Örebro University, Sweden

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 70185
        • Department of Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient-regulated compression
Patient-regulated compression device
Device: Patient-regulated compression device
Compression of the abdomen with a patient-regulated compression device
Active Comparator: Standard compression
Standard compression device
Device: Standard compression device
Compression of the abdomen with the standard compression device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dose measured as Dose-area product
Time Frame: Immediately
Radiation dose for the investigated exposures, measured as Dose-area product
Immediately

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality measured with Visual Grading
Time Frame: Immediately
Image quality for the investigated images, measured with Visual Grading
Immediately
Patient experience (questionnaire)
Time Frame: Immediately after the procedure
A questionnaire will be analysed with qualitative content analysis
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Investigators

  • Principal Investigator: Håkan Geijer, MD, PhD, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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