Contrast Media Temperature and Patient Comfort in CT of the Abdomen

Summary

Abdominal computed tomographic (CT) is an important prognostic tool with regard to the detection of oncological, infectious and other abdominal disorders.

The total iodine load (TIL) is regarded as a decisive factor in the opacification of parenchymal structures. The EICAR trial demonstrated that injection with high flow rates of prewarmed contrast media (CM) was safe and patients did not experience any pain, stress of discomfort during injection. Flow rates as high as 8.8 ml/s were injected without any discomfort. All concentrations used (e.g. 240, 300 and 370 mg I/ml) in this study were prewarmed. According to the recent recommendations (ESUR guidelines 10.0) it should be considered to warm iodine-based CM before administration. The hypothesis is that although using CM at room temperature (\~23°C \[\~73°F\]) might result in lower attenuation of the liver parenchyma than would be achieved using CM pre-warmed to body temperature, diagnostic image quality, patient safety and comfort will not be compromised by not pre-warming CM in this setting. According to the guidelines, it is regarded as best clinical practice to pre-warm CM. Surprisingly, these recommendations are merely based on a hypothetical assumption. In the literature, there are no studies evaluating this topic and it has never been clearly shown to result in a better patient comfort. For this reason, many clinics do not pre-warm their CM in daily clinical routine. Only one study evaluated subjective comfort in hysterosalpingography (HSG), in which CM is injected in to the cavity of the uterus. This study found that prewarmed CM alleviates the pain and decreased the incidence of vasovagal episodes during HSG. To the best of our knowledge, no study showed that prewarmed CM in CT resulted in higher patient comfort, in comparison to CM at room temperature (20° C).

Up till now, all CM in the department is prewarmed. In case this study does not show a difference in patient comfort, prewarming the CM can be stopped, resulting in a considerable simplified workflow.

The hypothesis is that usage of CM at room temperature (20° C) might result in a decreased level of patient comfort in abdominal CT, in comparison to pre-heated (37° C) CM, with no significant difference in diagnostic attenuation of the liver parenchyma between groups.

Conditions

• Contrast Media
• Comfort
• Temperature
• Abdomen

Interventions

OTHER

CM Temperature (20° C)

CM will be administered at 20° C (room temperature).

OTHER

CM Temperature (37° C)

CM will be administered at 37° C (pre-heated).

OTHER

Weight

The patients' weight is measured prior to scanning by a technician on a weighing scale available in the scanner room.

Sponsors & Collaborators

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Joachim E Wildberger, Professor · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-03

Primary Completion

2020-08-24

Completion

2020-08-24

Countries

• Netherlands

Study Locations