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)
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.
Secondary ID [1] 301959 0
Nil Known
Universal Trial Number (UTN)
U1111-1256-5318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural Sedation 318513 0
Condition category
Condition code
Emergency medicine 316518 316518 0 0
Other emergency care
Anaesthesiology 318030 318030 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 318245 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324654 0
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.
Timepoint [1] 324654 0
Cumulative data will be assessed six monthly throughout the study.
Primary outcome [2] 324655 0
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.
Timepoint [2] 324655 0
Cumulative data will be assessed six monthly throughout the study.
Secondary outcome [1] 385344 0
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.
Timepoint [1] 385344 0
Cumulative data will be assessed six monthly throughout the study.
Secondary outcome [2] 389889 0
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.
Timepoint [2] 389889 0
Cumulative data will be assessed six monthly throughout the study.
Secondary outcome [3] 389890 0
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.
Timepoint [3] 389890 0
Cumulative data will be assessed six monthly throughout the study.
Secondary outcome [4] 389891 0
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.
Timepoint [4] 389891 0
Cumulative data will be assessed six monthly throughout the study.
Secondary outcome [5] 389892 0
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.
Timepoint [5] 389892 0
Cumulative data will be assessed six monthly throughout the study.

Eligibility
Key inclusion criteria
All patients undergoing procedural sedation within Australian Emergency Departments on an ongoing basis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No specific exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 17200 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 30905 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 306383 0
University
Name [1] 306383 0
University of Tasmania
Country [1] 306383 0
Australia
Primary sponsor type
Individual
Name
Ashley Loughman
Address
Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
Country
Australia
Secondary sponsor category [1] 306885 0
Individual
Name [1] 306885 0
Viet Tran
Address [1] 306885 0
Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
Country [1] 306885 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306580 0
Tasmania Health & Medical Human Research Ethics Committee
Ethics committee address [1] 306580 0
Ethics committee country [1] 306580 0
Australia
Date submitted for ethics approval [1] 306580 0
15/01/2021
Approval date [1] 306580 0
Ethics approval number [1] 306580 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104358 0
Dr Ashley Loughman
Address 104358 0
Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
Country 104358 0
Australia
Phone 104358 0
+61 423535547
Fax 104358 0
Email 104358 0
ashley.loughman@ambulance.tas.gov.au
Contact person for public queries
Name 104359 0
Ashley Loughman
Address 104359 0
Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
Country 104359 0
Australia
Phone 104359 0
+61 423535547
Fax 104359 0
Email 104359 0
ashley.loughman@ambulance.tas.gov.au
Contact person for scientific queries
Name 104360 0
Ashley Loughman
Address 104360 0
Department of Emergency Medicine
Royal Hobart Hospital
48 Liverpool St
Hobart TAS 7000
Country 104360 0
Australia
Phone 104360 0
+61 423535547
Fax 104360 0
Email 104360 0
ashley.loughman@ambulance.tas.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.