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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621000198820p
Ethics application status
Submitted, not yet approved
Date submitted
6/08/2020
Date registered
25/02/2021
Date last updated
25/02/2021
Date data sharing statement initially provided
25/02/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
The Australian Emergency Procedural Sedation Database; A multi-centre observational study of the practice of Procedural Sedation in Australian Emergency Departments (ED)
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Scientific title
Prospective, multicentre, observational study of all patients undergoing Procedural Sedation in the Emergency Department to evaluate current practices, future trends and safety outcomes.
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Secondary ID [1]
301959
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Nil Known
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Universal Trial Number (UTN)
U1111-1256-5318
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Procedural Sedation
318513
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Condition category
Condition code
Emergency medicine
316518
316518
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0
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Other emergency care
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Anaesthesiology
318030
318030
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
We will record the indication for procedural sedation, the type of staff present and their roles, patient predicted markers of complexity, techniques (including medications, doses, monitoring and pre-oxygenation) and the occurrence of any complications prior to discharge from the emergency department. The study requires no active participation from patients, instead capturing data on current clinical practice via direct entry by clinicians into an electronic database. We aim to collect data for one year for initial evaluation with the goal of continuing on an ongoing basis.
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Intervention code [1]
318245
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Not applicable
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Comparator / control treatment
No Control Group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Efficacy of Emergency Department Procedural Sedation as defined by rates of procedural completion. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [1]
324654
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Timepoint [1]
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Cumulative data will be assessed six monthly throughout the study.
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Primary outcome [2]
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Safety of ED procedural sedation across participating sites. This will include rates of adverse events such as hypoxia, hypotension or need for airway support. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [2]
324655
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Timepoint [2]
324655
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Cumulative data will be assessed six monthly throughout the study.
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Secondary outcome [1]
385344
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Techniques in Emergency Procedural sedation will be assessed for medications, routes and doses used. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [1]
385344
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Timepoint [1]
385344
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Cumulative data will be assessed six monthly throughout the study.
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Secondary outcome [2]
389889
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Techniques in Emergency Procedural sedation will be assessed for staffing levels and clinician experience at performing sedation. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [2]
389889
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Timepoint [2]
389889
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Cumulative data will be assessed six monthly throughout the study.
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Secondary outcome [3]
389890
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Techniques in Emergency Procedural sedation will be assessed for monitoring modalities used during sedation. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [3]
389890
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Timepoint [3]
389890
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Cumulative data will be assessed six monthly throughout the study.
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Secondary outcome [4]
389891
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Techniques in Emergency Procedural sedation will be assessed for pre-oxygenation used during sedation. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [4]
389891
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Timepoint [4]
389891
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Cumulative data will be assessed six monthly throughout the study.
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Secondary outcome [5]
389892
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Patient oriented markers of predicted sedation complexity, such as predicted airway difficulty, cardio-respiratory compromise and presence of co-morbidities. These will be collected anonymously by clinician self reporting after performing procedural sedation. Clinicians will manually enter data onto an online database. Secondary methods such as digital medical records review will also be used where initial clinician self reporting data entry is incomplete.
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Assessment method [5]
389892
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Timepoint [5]
389892
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Cumulative data will be assessed six monthly throughout the study.
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Eligibility
Key inclusion criteria
All patients undergoing procedural sedation within Australian Emergency Departments on an ongoing basis
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No specific exclusion criteria
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
For publication purposes, all data will be entered in Microsoft Excel 2010 (Microsoft, Redmond, WA, USA) and analysed using SPSS PASW version 18.0 (SPSS, Inc., Chicago, IL, USA). Descriptive statistics will include median and inter- quartile range (IQR from the 25th to the 75th percentile). T2 test or, as appropriate, exact tests will be used to compare groups of categorical data and to test for trends. For all analyses, actual P-values will be reported and all tests will be two-tailed. Statistically significant differences will be considered at the P < 0.05 level, and 95% confidence intervals (CI) will be presented where possible.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
17200
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Royal Hobart Hospital - Hobart
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Recruitment postcode(s) [1]
30905
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7000 - Hobart
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Funding & Sponsors
Funding source category [1]
306383
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University
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Name [1]
306383
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University of Tasmania
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Address [1]
306383
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Churchill Ave
Hobart TAS 7005
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Country [1]
306383
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Australia
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Primary sponsor type
Individual
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Name
Ashley Loughman
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Address
Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
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Country
Australia
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Secondary sponsor category [1]
306885
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Individual
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Name [1]
306885
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Viet Tran
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Address [1]
306885
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Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
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Country [1]
306885
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
306580
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Tasmania Health & Medical Human Research Ethics Committee
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Ethics committee address [1]
306580
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University of Tasmania
Churchill Ave
Hobart TAS 7005
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Ethics committee country [1]
306580
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Australia
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Date submitted for ethics approval [1]
306580
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15/01/2021
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Approval date [1]
306580
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Ethics approval number [1]
306580
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Summary
Brief summary
Procedural sedation to facilitate painful and non-painful procedures is a core skill of specialist emergency physicians (EPs) in Australasia. Our goal is to establish a national procedural sedation dataset to monitor practice for trends in techniques and safety on a large scale over time. This will collect data on current practices around procedural sedation, including patient selection and optimisation, staffing, medication use, monitoring modalities and rates of procedural success and sedation complications. We hope that this database will form fertile ground for the exploration of future research hypotheses.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ashley Loughman
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Address
104358
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Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
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Country
104358
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Australia
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Phone
104358
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+61 423535547
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Fax
104358
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Email
104358
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[email protected]
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Contact person for public queries
Name
104359
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Dr Ashley Loughman
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Address
104359
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Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
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Country
104359
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Australia
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Phone
104359
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+61 423535547
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Fax
104359
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Email
104359
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[email protected]
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Contact person for scientific queries
Name
104360
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Dr Ashley Loughman
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Address
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Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
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Country
104360
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Australia
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Phone
104360
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+61 423535547
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Fax
104360
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Email
104360
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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