ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1271-2645

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Procedural Sedation

Condition category

Condition code

Emergency medicine

Other emergency care

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Data will be analysed 6-monthly for 20 years.

Secondary outcome [1]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal North Shore Hospital Emergency Department

Address [1]

Reserve Rd, St Leonards, NSW 2065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee (NSLHD HREC)

Ethics committee address [1]

Level 14, Kolling Building, Westbourne Rd, St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/11/2021

Approval date [1]

25/11/2021

Ethics approval number [1]

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

Dr Sean Baldwin

Address

Emergency Department,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9463 2200

Fax

[email protected]

Contact person for public queries

Name

Sean Baldwin

Address

Emergency Department,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9463 2200

Fax

[email protected]

Contact person for scientific queries

Name

Sean Baldwin

Address

Emergency Department,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9463 2200

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13980	Study 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.

Trial Review

Documents added manually

Documents added automatically