- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01232088
Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling
October 30, 2015 updated by: Claudia Spies, Charite University, Berlin, Germany
Medication errors are common in intensive care (Valentin A et al., BMJ.
2009;338).
Standardized color coded labels for user applied syringes enjoy strong support from many health professionals, thinking that this might increase patient safety.
Whether this is true or not warrants further research.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
482
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 13353/10117
- Department of Anesthesiology and Intensive Care Medicine Campus Virchow Klinikum/Campus Charité Mitte
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Members of the European Society of Intensive Care Medicine (ESICM)
Description
Inclusion Criteria:
Members of the European Society of Intensive Care Medicine (ESICM)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Data collection group: ICU physicians
Online survey for ICU physicians (members of the European Society of Intensive Care Medicine (ESICM)).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary objective is to assess if standardized drug syringe labelling is used in European ICUs.
Time Frame: A period of 90 days.
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Online survey for ICU physicians (members of the ESICM).
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A period of 90 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The second objectives is to assess 1. if standards for drug syringe labelling are similar in European ICUs and 2. if users expect that standardized drug syringe labelling should be delivered by the pharmaceutical industry.
Time Frame: A period of 90 days
|
Online survey for ICU physicians (members of the ESICM).
|
A period of 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Valentin A, Capuzzo M, Guidet B, Moreno R, Metnitz B, Bauer P, Metnitz P; Research Group on Quality Improvement of the European Society of Intensive Care Medicine (ESICM); Sentinel Events Evaluation (SEE) Study Investigators. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009 Mar 12;338:b814. doi: 10.1136/bmj.b814.
- Balzer F, Wickboldt N, Spies C, Walder B, Goncerut J, Citerio G, Rhodes A, Kastrup M, Boemke W. Standardised drug labelling in intensive care: results of an international survey among ESICM members. Intensive Care Med. 2012 Aug;38(8):1298-305. doi: 10.1007/s00134-012-2569-1. Epub 2012 Apr 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 1, 2010
First Posted (ESTIMATE)
November 2, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Standardized Drug Labelling
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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