Contrast Media Temperature and Patient Comfort in CT of the Abdomen

NCT04249479 | Completed DMC

• 1 other identifier: NL68789.068.19
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Patient comfort

  Immediately after CT

• Pain during injection

  Questionnaire immediately after CT

• Pain rate

  Questionnaire immediately after CT

• Different physiological reactions and sensations injection

  Immediately after the CT

• Objective image quality - Signal-to-noise ratio

  Within one month after the CT is performed

Study Arms (2)

CM temperature 20° C

EXPERIMENTAL

CM is administered to the patient at a temperature of 20° C.

Other: CM Temperature (20° C); Other: Weight

CM temperature 37° C

ACTIVE COMPARATOR

CM is administered to the patient at a temperature of 37° C.

Other: CM Temperature (37° C); Other: Weight

Interventions

CM Temperature (20° C) OTHER

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

CM temperature 20° C

CM Temperature (37° C) OTHER

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

CM temperature 37° C

Weight OTHER

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

CM temperature 20° C; CM temperature 37° C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for abdominal CT
• Patient ≥ 18 years old and competent to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• Martens B, Wildberger JE, Van Kuijk SMJ, De Vos-Geelen J, Jeukens CRLPN, Mihl C. Influence of Contrast Material Temperature on Patient Comfort and Image Quality in Computed Tomography of the Abdomen: A Randomized Controlled Trial. Invest Radiol. 2022 Feb 1;57(2):85-89. doi: 10.1097/RLI.0000000000000807.

  PMID: 34280944 DERIVED

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Joachim E Wildberger, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All subjects will be randomized into two different groups as listed in the study outline. The randomization schedule will be prepared and centrally administered. A computer random number generator prepares the randomization schedule in a 1:1 fashion (balanced randomization). Stratification is performed, based on age (\< 60 and ≥ 60 years) and weight (\< 80 and ≥ 80 kg). Variable block randomization will distribute patients equally over time. The blinding and randomization process will be conducted by Clinical Trial Centre Maastricht (CTCM, www.CTCM.nl) with a randomization program designed for usage of different techniques (minimization, block method, biased-coin, etc). The technician who administers the CM is aware of the CM temperature. Therefore, the technicians will be instructed before start of the study, not to give this information to the patient, not even when requested by the patient.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a double-blinded randomised controlled non-inferiority trial conducted according to Guidelines of Good Clinical Practice. The aim of the study is to prospectively compare room temperature CM to pre-warmed CM with regard to image quality, safety, and participant comfort in portal venous abdominal imaging. We are aiming to prospectively enrol 216 consecutive patients, who will be scheduled for contrast enhanced abdominal CT. 216 patients will be divided into 2 different groups: * Group I: 300 mg/ml at a temperature of 20° C * Group II: 300 mg/ml at a temperature of 37° C Iodine concentrated CM of 300 mg/ml is clinically used as a standard routine injection protocol for all CT scans in our department, including abdominal CT. The scan protocol is identical to our daily clinical practice. The only difference is that 50% of the included patients will receive CM warmed at room temperature. Both CM temperatures are saved/warmed in an incubator.

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: January 31, 2020
• Study Start: February 3, 2020
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Within 18 months after completion

Locations

NL (1)