Influence of Contrast Material Temperature on Patient Comfort and Image Quality in Computed Tomography of the Abdomen: A Randomized Controlled Trial.
Journal
Investigative radiology
ISSN: 1536-0210
Titre abrégé: Invest Radiol
Pays: United States
ID NLM: 0045377
Informations de publication
Date de publication:
01 02 2022
01 02 2022
Historique:
pubmed:
20
7
2021
medline:
15
4
2022
entrez:
19
7
2021
Statut:
ppublish
Résumé
International guideline recommendations on safe use of contrast media (CM) are conflicting regarding the necessity to prewarm iodinated CM. Aim of the study was to evaluate the effects of room temperature CM compared with prewarmed CM on image quality, safety, and patient comfort in abdominal computed tomography (CT). CATCHY (Contrast Media Temperature and Patient Comfort in Computed Tomography of the Abdomen) is a double-blinded, randomized noninferiority trial. Between February and August 2020, 218 participants referred for portal venous abdominal CT were prospectively and randomly assigned to 1 of 2 groups. All patients received iopromide at 300 mg I/mL: group 1 at room temperature (~23°C [~73°F]) and group 2 prewarmed to body temperature (37°C [99°F]). A state-of-the-art individualized CM injection protocol was used, based on body weight and adapted to tube voltage. Primary outcome was absolute difference in mean liver attenuation between groups, calculated with a 2-sided 95% confidence interval. The noninferiority margin was set at -10 HU. Secondary outcomes were objective (signal-to-noise ratio and contrast-to-noise ratio) and subjective image quality; CM extravasations and other adverse events; and participant comfort (5-point scale questionnaire) and pain (numeric rating scale). This trial is registered with ClinicalTrials.gov (NCT04249479). The absolute difference in mean attenuation between groups was + 4.23 HU (95% confidence interval, +0.35 to +8.11; mean attenuation, 122.2 ± 13.1 HU in group 1, 118.0 ± 15.9 HU in group 2; P = 0.03). Signal-to-noise ratio, contrast-to-noise ratio, and subjective image quality were not significantly different between groups (P = 0.53, 0.23, and 0.99 respectively). Contrast extravasation occurred in 1 patient (group 2), and no other adverse events occurred. Comfort scores were significantly higher in group 1 than in group 2 (P = 0.03); pain did not significantly differ (perceived P > 0.99; intensity P = 0.20). Not prewarming iodinated CM was found noninferior in abdominal CT imaging. Prewarming conferred no beneficial effect on image quality, safety, and comfort, and might therefore no longer be considered a prerequisite in state-of-the art injection protocols for parenchymal imaging.
Sections du résumé
BACKGROUND
International guideline recommendations on safe use of contrast media (CM) are conflicting regarding the necessity to prewarm iodinated CM.
PURPOSE
Aim of the study was to evaluate the effects of room temperature CM compared with prewarmed CM on image quality, safety, and patient comfort in abdominal computed tomography (CT).
METHODS
CATCHY (Contrast Media Temperature and Patient Comfort in Computed Tomography of the Abdomen) is a double-blinded, randomized noninferiority trial. Between February and August 2020, 218 participants referred for portal venous abdominal CT were prospectively and randomly assigned to 1 of 2 groups. All patients received iopromide at 300 mg I/mL: group 1 at room temperature (~23°C [~73°F]) and group 2 prewarmed to body temperature (37°C [99°F]). A state-of-the-art individualized CM injection protocol was used, based on body weight and adapted to tube voltage. Primary outcome was absolute difference in mean liver attenuation between groups, calculated with a 2-sided 95% confidence interval. The noninferiority margin was set at -10 HU. Secondary outcomes were objective (signal-to-noise ratio and contrast-to-noise ratio) and subjective image quality; CM extravasations and other adverse events; and participant comfort (5-point scale questionnaire) and pain (numeric rating scale). This trial is registered with ClinicalTrials.gov (NCT04249479).
RESULTS
The absolute difference in mean attenuation between groups was + 4.23 HU (95% confidence interval, +0.35 to +8.11; mean attenuation, 122.2 ± 13.1 HU in group 1, 118.0 ± 15.9 HU in group 2; P = 0.03). Signal-to-noise ratio, contrast-to-noise ratio, and subjective image quality were not significantly different between groups (P = 0.53, 0.23, and 0.99 respectively). Contrast extravasation occurred in 1 patient (group 2), and no other adverse events occurred. Comfort scores were significantly higher in group 1 than in group 2 (P = 0.03); pain did not significantly differ (perceived P > 0.99; intensity P = 0.20).
CONCLUSIONS
Not prewarming iodinated CM was found noninferior in abdominal CT imaging. Prewarming conferred no beneficial effect on image quality, safety, and comfort, and might therefore no longer be considered a prerequisite in state-of-the art injection protocols for parenchymal imaging.
Identifiants
pubmed: 34280944
doi: 10.1097/RLI.0000000000000807
pii: 00004424-202202000-00002
doi:
Substances chimiques
Contrast Media
0
Banques de données
ClinicalTrials.gov
['NCT04249479']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
85-89Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of interest and sources of funding: This manuscript has not received any funding. The authors report no conflicts of interest. However, the authors declare relationships with the following companies: C.M. and B.M. receive personal fees (speakers bureau) from Bayer. J.D.V.-G. has served as a consultant for Amgen, AstraZeneca, MSD, Pierre Fabre, and Servier, and has received institutional research funding from Servier, all outside the submitted work. J.E.W. reports institutional research grants from Agfa, Bard, Bayer, GE, Philips, Optimed, and Siemens and personal fees (speakers bureau) from Siemens and Bayer, all outside the submitted work.
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