Patient-driven Compression in Urography

Urologic Diseases Clinical Trial

Official title:

Patient-driven Compression in Urography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622269
• Other study ID #: 183781
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: February 24, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Urologic Diseases

Intervention

Device:
• Patient-regulated compression device
Compression of the abdomen with a patient-regulated compression device
• Standard compression device
Compression of the abdomen with the standard compression device

Locations

Country	Name	City	State
Sweden	Department of Radiology	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose measured as Dose-area product	Radiation dose for the investigated exposures, measured as Dose-area product	Immediately	No
Secondary	Image quality measured with Visual Grading	Image quality for the investigated images, measured with Visual Grading	Immediately	No
Secondary	Patient experience (questionnaire)	A questionnaire will be analysed with qualitative content analysis	Immediately after the procedure	No