Types of participants
This review will consider studies that included patients (adults or children), undergoing a CT examination, for any indication and of any part of the body, and requiring use of an IV administration of contrast media material. The examination can be either a classical CT or an interventional radiology CT procedure. The participants may be either inpatients or ambulatory care patients.
This review will not consider studies investigating extravasations in the framework of chemotherapy, anaesthesiology or parenteral nutrition. Indeed, the products used present a very different composition and thus different properties (e.g. viscosity and toxicity) compared to contrast media.
Types of intervention(s)/phenomena of interest
This review will consider studies that evaluated interventions or protocols which may prevent extravasation of contrast media or reduce its severity. Accordingly, it will include any strategies, related to:
- The contrast agent (volume, concentration, viscosity, temperature)
- The injection per se (patient injection site, preparation room)
- The material used for injection (catheter gauge, cannulas, butterfly, venflon)
- The apparatus used (detection device: ultrasound, radiofrequency)
- The healthcare professionals (profession, skills)
- The patient risk assessment by the radiology personnel (medication, morbidity, language).
The comparators of this study will be either other interventions -such as a different contrast agent, another cannula- or usual care -such as the absence of preparation room or detection device.
Types of outcomes
This review will consider studies that include the primary and secondary outcomes described below.
Primary patient outcomes will include:
- Extravasation frequency
- Extravasation volume
- Extravasation severity, including inflammatory reactions, necrosis, pain
- Complications, including plastic surgery and amputation
Secondary outcome measures will include:
- Diagnostic value and accuracy
- False positive detection of extravasation. This outcome is particular to the interventions using detection device.
Types of studies
This review will consider both experimental and epidemiological study designs including randomized controlled trials and non-randomized controlled trials. In the absence of these trials, other study designs, such as quasi-experimental, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies will be considered for inclusion. In the absence of significant analytical literature on this topic, then descriptive epidemiological study designs including case series, individual case reports and descriptive cross sectional studies will be considered for inclusion.
The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilised in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the retrieved titles and abstracts and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published, in English and French, from 1980 to June 2014 will be considered for inclusion in this review.
The databases to be searched will include: CINHAL, Embase, Medline, The Cochrane register of controlled trials, Web of knowledge, PsycINFO.
The search for unpublished studies will include: ProQuest Dissertation & Theses Database, TripDatabase, Clinical trials
Initial keywords to be used will be:
Extravasation, contrast media, computed tomography, prevention, healthcare professionals, frequency, volume, complications
Assessment of methodological quality
Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements between the reviewers will be resolved through discussion, or with a third reviewer.
Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for missing information or to clarify unclear data.
The primary objective is to pool all quantitative data, where possible, for statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry by the two reviewers. Effect sizes (expressed as an odds ratio for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square test and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling will not be possible, the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.
Conflicts of interest
There is no conflict of interest regarding this systematic review.
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Appendix I: Appraisal instruments
MAStARI appraisal instrument
Appendix II: Data extraction instruments
MAStARI data extraction instrument