NCT04249479: CATCHY

Contrast Media Temperature and Patient Comfort in CT of the Abdomen

Completed NA Last updated 2 April 2021

What this trial tests

NA trial testing CM Temperature (20° C) in Contrast Media in 218 participants. Completed in 24 August 2020.

Timeline

3 February 2020

Primary endpoint
24 August 2020

24 August 2020

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	218
Start date	3 February 2020
Primary completion	24 August 2020
Estimated completion	24 August 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• CM Temperature (20° C)
• CM Temperature (37° C)
• Weight

Conditions studied

• Contrast Media — all drugs for Contrast Media →
• Comfort — all drugs for Comfort →
• Temperature — all drugs for Temperature →
• Abdomen — all drugs for Abdomen →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Contrast Media or Comfort. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Influence of Contrast Material Temperature on Patient Comfort and Image Quality in Computed Tomography of the Abdomen: A Randomized Controlled Trial.
   Martens B, Wildberger JE, Van Kuijk SMJ, De Vos-Geelen J, et al · · 2022 · cited 6× · PMID 34280944 · DOI 10.1097/rli.0000000000000807