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

NCT06912464 | Not Yet Recruiting

• 1 other identifier: 20649
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Transportation of Patients; PET / CT; Intensive Care Medicine

Keywords

Intrahospital transport (IHT); Intensive Care Medicine; ICU; PET; PET/CT; Safety; CT

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  All adverse events associated with imaging procedures (PET and CT) This will encompass (amongst others) oxygen desaturation, bronchospasm, accidental extubation, hypo-/hypertension, cardiac arrest, malfunctioning medical devices, lack of necessary medication etc.) Timeframe: Start transport to PET/CT scanner and 4 hours hands-off time. We will score the noted adverse events in a grading scale adapted from the Clavien-Dindo classification that surgeons use to grade the severity of post-operative complications.

  Measured during the transport phase and 4 hours after return to the Intensive Care Unit.

Secondary Outcomes (3)

• Employee dosimetry

  Transport and the hands-off time after scan (i.e. 4h in case of [18]FDG PET scanning)

• Dietary Adjustment

  24-48 hours before scan procedure and until 24 hours after cessation of the diet.

• Kidney failure (KDIGO)

  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))

Study Arms (2)

PET/CT

Patients undergoing a PET/CT for any reason will be evaluated for safety.

CT

All patients undergoing a (planned) CT-Thorax/Abdomen will be included in the analysis.

Eligibility Criteria

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

Study Population

Only patients admitted to the Intensive Care Unit (ICU) will be studied.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (11)

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  PMID: 34136956 BACKGROUND

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  PMID: 23863225 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Brunsveld-Reinders AH, Arbous MS, Kuiper SG, de Jonge E. A comprehensive method to develop a checklist to increase safety of intra-hospital transport of critically ill patients. Crit Care. 2015 May 7;19(1):214. doi: 10.1186/s13054-015-0938-1.

  PMID: 25947327 BACKGROUND

• van Leer B, van Rijsewijk ND, Nijsten MWN, Slart RHJA, Pillay J, Glaudemans AWJM. Practice of 18F-FDG-PET/CT in ICU Patients: A Systematic Review. Semin Nucl Med. 2023 Nov;53(6):809-819. doi: 10.1053/j.semnuclmed.2023.05.003. Epub 2023 May 29.

  PMID: 37258380 BACKGROUND

• van Snick JH, van Leer B, Nijsten MWN, Pillay J, Slart RHJA, Glaudemans AWJM, van Rijsewijk ND. Long axial field of view PET/CT in critically ill patients: lessons from a case report. Front Med (Lausanne). 2024 Jan 4;10:1347791. doi: 10.3389/fmed.2023.1347791. eCollection 2023.

  PMID: 38239612 BACKGROUND

Central Study Contacts

Cornelis Paul Van Stee, MD

CONTACT

+31655256893; fapi-ards@umcg.nl

Janesh Pillay, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once data collection has been completed, data will be made available on request. Ergo circa April 2027.
• Access Criteria: Only data gathered to answer the primary research question posed in this study will be made available and only upon request via the primary researcher.

Locations

NL (1)