To Evaluate Transport Safety Between Different Scanning Methods for Patients in the Intensive Care Unit (ICU)

Official title

Comparative Safety Analysis: PET vs. CT Scans During Intensive Care Admission

Overview

The goal of this study is to assess how safe it is for critically ill patients in the Intensive Care Unit (ICU) to undergo a PET scan. A PET scan is a type of medical imaging used to help determine why a patient is sick. It is similar to a CT scan but involves a small amount of radioactivity to highlight areas of concern in the body. For a PET scan, patients need to be transported from the ICU to the scanning room, which can be risky because ICU patients are often very fragile. After a patient gets the PET scan injection, their body gives off a small amount of radiation for a short time. Because of this, doctors and nurses have to keep some distance to protect themselves. This means they keep an eye out for the patient from a bit further away than normal. This makes the procedure slightly riskier, especially for very sick patients. This study aims to answer the question: Is getting a PET scan riskier for ICU patients than a regular CT scan? All patients in this study will continue to receive their usual critical care. Researchers will closely monitor the scanning process to evaluate its safety. PET scans are already widely used to detect cancer, but new advancements may allow us to use them more often to diagnose infections. Before this can become routine practice, we need to ensure that PET scanning is just as safe as other commonly used imaging techniques. This study will assess all ICU patients undergoing a PET scan-regardless of the reason for the scan-to determine how safe the procedure is in critically ill individuals.

Primary outcome measures

• Adverse Events [Time frame: Measured during the transport phase and 4 hours after return to the Intensive Care Unit.]

Secondary outcome measures (3)

• Employee dosimetry [Time frame: Transport and the hands-off time after scan (i.e. 4h in case of [18]FDG PET scanning)]
• Dietary Adjustment [Time frame: 24-48 hours before scan procedure and until 24 hours after cessation of the diet.]
• Kidney failure (KDIGO) [Time frame: Day of the scan and up to 3 days after the scan to evaluate the effect on kidney function (i.e. creatinine and urine creatinine will be measured 4 times and evaluated for significant alterations after the application of iodine contrast (if given))]

Eligibility criteria

Inclusion criteria

• Patients receiving PET/CT during ICU admission (any indication)
• Patients undergoing CT Thorax/Abdomen (matched cohort)

Exclusion criteria

• CT-scan for any acute indication (acute danger to vital parameters).
• CT-Cerebrum
• Registrion in the dutch Objection to medical research registry.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Netherlands · 1 center

• University Medical Center Groningen — Groningen

Publications

• Baldetti L, Busnardo E, Pazzanese V, Ricchetti G, Barone G, Sacchi S, Calvo F, Gramegna M, Pieri M, Ingallina G, Camici PG, Ajello S, Scandroglio AM. Myocardial viability assessment during Impella support with 18-fluorodesoxyglucose PET imaging. ESC Heart Fail. 2025 Feb;12(1):683-687. doi: 10.1002/ehf2.15053. Epub 2024 Sep 6. PMID 39239887
• Slart RHJA, Tsoumpas C, Glaudemans AWJM, Noordzij W, Willemsen ATM, Borra RJH, Dierckx RAJO, Lammertsma AA. Long axial field of view PET scanners: a road map to implementation and new possibilities. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4236-4245. doi: 10.1007/s00259-021-05461-6. Epub 2021 Jun 16. PMID 34136956
• Schwebel C, Clec'h C, Magne S, Minet C, Garrouste-Orgeas M, Bonadona A, Dumenil AS, Jamali S, Kallel H, Goldgran-Toledano D, Marcotte G, Azoulay E, Darmon M, Ruckly S, Souweine B, Timsit JF; OUTCOMEREA Study Group. Safety of intrahospital transport in ventilated critically ill patients: a multicenter cohort study*. Crit Care Med. 2013 Aug;41(8):1919-28. doi: 10.1097/CCM.0b013e31828a3bbd. PMID 23863225
• Bercault N, Wolf M, Runge I, Fleury JC, Boulain T. Intrahospital transport of critically ill ventilated patients: a risk factor for ventilator-associated pneumonia--a matched cohort study. Crit Care Med. 2005 Nov;33(11):2471-8. doi: 10.1097/01.ccm.0000185644.54646.65. PMID 16276168
• Parmentier-Decrucq E, Poissy J, Favory R, Nseir S, Onimus T, Guerry MJ, Durocher A, Mathieu D. Adverse events during intrahospital transport of critically ill patients: incidence and risk factors. Ann Intensive Care. 2013 Apr 12;3(1):10. doi: 10.1186/2110-5820-3-10. PMID 23587445
• Waydhas C. Intrahospital transport of critically ill patients. Crit Care. 1999;3(5):R83-9. doi: 10.1186/cc362. Epub 1999 Sep 24. PMID 11094486
• Murata M, Nakagawa N, Kawasaki T, Yasuo S, Yoshida T, Ando K, Okamori S, Okada Y. Adverse events during intrahospital transport of critically ill patients: A systematic review and meta-analysis. Am J Emerg Med. 2022 Feb;52:13-19. doi: 10.1016/j.ajem.2021.11.021. Epub 2021 Nov 20. PMID 34861515
• Venkategowda PM, Rao SM, Mutkule DP, Taggu AN. Unexpected events occurring during the intra-hospital transport of critically ill ICU patients. Indian J Crit Care Med. 2014 Jun;18(6):354-7. doi: 10.4103/0972-5229.133880. PMID 24987233

Identifiers

NCT: NCT06912464 · 20649

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗