Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000095763
Ethics application status
Approved
Date submitted
5/11/2021
Date registered
24/01/2022
Date last updated
9/01/2023
Date data sharing statement initially provided
24/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
ProSed Australasia: A database of procedural sedation practices and outcomes in Australasian Emergency Departments
Scientific title
ProSed Australasia: A database of procedural sedation performed in Australasian Emergency Departments for analysis of the interaction between medications used, doses used, adverse events, procedure success rates, and outcomes
Secondary ID [1] 305734 0
None
Universal Trial Number (UTN)
U1111-1271-2645
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural Sedation 324225 0
Condition category
Condition code
Emergency medicine 321709 321709 0 0
Other emergency care
Anaesthesiology 322277 322277 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
Our registry will include all patients undergoing procedural sedation in the emergency department at the involved sites. The observation will continue until the end of the sedation once the patient is waking up, less than an hour. Information will be recorded regarding the indication for sedation, where it was performed, who performed it, patient weight, American Society of Anesthesiologists (ASA) grade, medications given for the procedure, adverse events, management required, deepest level of sedation achieved, and disposition.

Data will be entered into a form by the clinician performing the procedure, to happen as soon as possible after the procedure takes place.

Data will be collected for 20 years.
Intervention code [1] 322129 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329468 0
Rate of adverse events experienced by patients undergoing procedural sedation, subclassified into minor/moderate/severe adverse events. These events will be identified by our audit of study records from the form completed by the clinician performing the sedation.
Timepoint [1] 329468 0
Data will be analysed 6-monthly for 20 years.
Secondary outcome [1] 402719 0
Incidence of hypotension (SBP <90 mmHg) experienced by patients undergoing procedural sedation, stratified by drug used and dose per kilogram. These events will be identified by our audit of study records from the form completed by the clinician performing the sedation.
Timepoint [1] 402719 0
Data will be analysed annually for 20 years.

Eligibility
Key inclusion criteria
All patients undergoing procedural sedation at a participating site.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The initial 3 months of data will be analysed for our initial safety study examining rates of adverse events in our practice to compare to published international literature. Further studies will be planned using this data on a case-by-case basis for the particular association being analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/12/2021
Date of last participant enrolment
Anticipated
31/12/2041
Actual
Date of last data collection
Anticipated
31/12/2041
Actual
Sample size
Target
10000
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21035 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 35875 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 310091 0
Hospital
Name [1] 310091 0
Royal North Shore Hospital Emergency Department
Country [1] 310091 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Kolling Building, Level 14/10 Westbourne St, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 311153 0
None
Name [1] 311153 0
Address [1] 311153 0
Country [1] 311153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309781 0
Northern Sydney Local Health District Human Research Ethics Committee (NSLHD HREC)
Ethics committee address [1] 309781 0
Level 14, Kolling Building, Westbourne Rd, St Leonards NSW 2065
Ethics committee country [1] 309781 0
Australia
Date submitted for ethics approval [1] 309781 0
05/11/2021
Approval date [1] 309781 0
25/11/2021
Ethics approval number [1] 309781 0
2021/ETH12032

Summary
Brief summary
Procedural sedation involves the administration of sedative medications to facilitate a painful or intolerable procedure. It is commonly performed in emergency departments for reduction of a range of orthopaedic injuries, to facilitate cardioversion for tachyarrhythmias, amongst other uses.

The usual practice involves one clinician performing sedation, another clinician performing a procedure, and a nurse assisting with medications, monitoring and documentation. It is generally performed in a resuscitation bay to be prepared for any complications that may arise.

Procedural sedation is commonly performed in Australasian emergency departments however the evidence base for the practice of it is not as robust as many other areas. Drugs used for procedural sedation have changed over time with introduction of newer agents, however there remains a lack of evidence as to best practices. As such the administration of procedural sedation varies widely with significant variation within departments and even wider variation internationally.

We are establishing a database of all procedural sedation performed at our hospital with a view to expanding this database state-wide and eventually throughout Australasia. This large dataset will allow us to analyse the sedation performed and draw associations between the patients involved, the medications used, adverse events, and procedure success rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115366 0
Dr Sean Baldwin
Address 115366 0
Emergency Department,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065
Country 115366 0
Australia
Phone 115366 0
+61 2 9463 2200
Fax 115366 0
Email 115366 0
[email protected]
Contact person for public queries
Name 115367 0
Sean Baldwin
Address 115367 0
Emergency Department,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065
Country 115367 0
Australia
Phone 115367 0
+61 2 9463 2200
Fax 115367 0
Email 115367 0
[email protected]
Contact person for scientific queries
Name 115368 0
Sean Baldwin
Address 115368 0
Emergency Department,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065
Country 115368 0
Australia
Phone 115368 0
+61 2 9463 2200
Fax 115368 0
Email 115368 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13980Study protocol  [email protected] 383077-(Uploaded-06-01-2022-14-46-28)-Study-related document.pdf



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.