Clinical trial NCT06912464: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transportation of Patients
PET / CT
Intensive Care Medicine
Keywords: Intrahospital transport (IHT)
Intensive Care Medicine
ICU
PET
PET/CT
Safety
CT
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients admitted to the Intensive Care Unit (ICU) will be studied.

Brief summary: 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.


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.

Primary outcomes:
measure: Adverse Events
timeFrame: Measured during the transport phase and 4 hours after return to the Intensive Care Unit.
Secondary outcomes:
measure: Employee dosimetry
timeFrame: Transport and the hands-off time after scan (i.e. 4h in case of [18]FDG PET scanning)
measure: Dietary Adjustment
timeFrame: 24-48 hours before scan procedure and until 24 hours after cessation of the diet.
measure: Kidney failure (KDIGO)
timeFrame: 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))
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
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