Comfort Clinical Trial
— CATCHYOfficial title:
The Effect of ContrAst Media Temperature on Patient Comfort in Computed tomograpHY of the Abdomen.
Verified date | March 2021 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 218 |
Est. completion date | August 24, 2020 |
Est. primary completion date | August 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria - Patients referred for abdominal CT - Patient = 18 years old and competent to sign informed consent Exclusion criteria - Hemodynamic instability - Pregnancy - Renal insufficiency defined as glomerular filtration rate (GFR) < 30ml/min/1.73m2 (Odin protocol 004720) - Iodine allergy (Odin protocol 022199) - Age < 18 year - Unable to give informed consent or no informed consent obtained - Inability to position an 18 gauge cannula in an antecubital vein |
Country | Name | City | State |
---|---|---|---|
Netherlands | MaastrichtUMC | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver attenuation | Mean attenuation in Hounsfield Units (HU) is based on three liver segments, preferably segments 2, 5 and 8 (Couinaud classification). Absolute difference in mean attenuation of the liver parenchyma between groups was calculated with a two-sided 95% confidence interval of the difference. | Expected within one month after the CT is performed | |
Secondary | Patient comfort | Patient (dis)comfort during and after injection of CM with varying temperatures, rated on a questionnaire | Immediately after CT | |
Secondary | Pain during injection | Assessed with a questionnaire with the option yes/no | Questionnaire immediately after CT | |
Secondary | Pain rate | Assessed with a 11-point numeric rating scale (0=no pain; 10=very severe pain) | Questionnaire immediately after CT | |
Secondary | Different physiological reactions and sensations injection | Questionnaire has to be filled in which people can tick a box if they had feelings of shivering/goosebumps/or being cold. There is some free space to write down other sensations. | Immediately after the CT | |
Secondary | Objective image quality - Signal-to-noise ratio | mean attenuation of the liver divided by the mean standard deviation | Within one month after the CT is performed | |
Secondary | Objective image quality - Contrast-to-noise ratio | Mean liver attenuation minus HU of the left paraspinal muscle, divided by the SD of the attenuation of the paraspinal muscle | Within one month after the CT is performed | |
Secondary | Subjective image quality | Rated in consensus on a 5-point Likert scale by two readers | Within one month after the end of the study | |
Secondary | Body weight | Weight is measured on a weighing scale | Right before the scan is performed | |
Secondary | CM volume | The milliliter of CM administered | Information is expected to be collected from the Certegra form available in Impax within 1 month | |
Secondary | Flow rate | Flow rate of the contrast media in ml/s | Information is expected to be collected from the Certegra form available in Impax within 1 month | |
Secondary | Injection site | Injection site of the CM | Information is expected to be collected from the Certegra form available in Impax within 1 month | |
Secondary | Catheter Gauge | Catheter size used for CM injection | Information is expected to be collected from the Certegra form available in Impax within 1 month | |
Secondary | Effective milliamperes (mAs) | The effective mAs used in the specific patient | Information is expected to be collected from the Certegra form available in Impax within 1 month | |
Secondary | CT Dose Index (CTDI)vol | CTDIvol (in mGy) the patient received | Information is expected to be collected from Impax within 1 month | |
Secondary | Dose-length product (DLP) | DLP (in mGycm) the patient received | Information is expected to be collected from Impax within 1 month | |
Secondary | Tube voltage | Tube voltage used in the specific scan | Information is expected to be collected from Impax within 1 month |
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