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Trial registered on ANZCTR


Registration number
ACTRN12616000292471
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
7/03/2016
Date last updated
12/05/2022
Date data sharing statement initially provided
20/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Procedural Sedation in the Emergency Department: Prospective
Data Collection
Scientific title
Prospective data collection for procedural sedation performed in the Emergency Department
Secondary ID [1] 288558 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural sedation in the ED 297671 0
Condition category
Condition code
Anaesthesiology 297852 297852 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
Procedural sedation in the ED, All procedures involving sedation which occur in the ED during the study period, will be observed by study staff and complications monitored as they occur. Participants will also then be contacted by telephone 1-6 weeks post sedative episode to assess any further complications which occurred following discharge. Patients are observed for the duration of the ED sedative episode, generally 45 minutes or thereabouts, for the recovery period (generally 1 hour), and as well will be followed up by phone between 1 and 6 weeks post discharge from the ED. Patients who are unable to be contacted during this 1-6 week time frame will have phone contact attempts made for up to 3 months. After this point, if still uncontactable, patients willbe deemed lost to follow-up
Intervention code [1] 293936 0
Not applicable
Comparator / control treatment
No control group, observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297377 0
Major airway complications: Aspiration pneumonitis and/or intubation.
Aspiration pneumonitis assessed clinically by the occurence of cough, wheeze, O2 desaturations (as per pulse oximiter) and new Chest Xray findings consistent with aspiration pneumonitis (Features can be variable and can range from a pulmonary oedema pattern to areas of consolidation or new infiltrates. These changes may have a gravity dependant distribution)
Intubation is assessed by whether the patient is intubated or not.
,
Timepoint [1] 297377 0
During ED visit, in sedative period, (usually 45 minutes or so from start point of sedation) and the immediate recovery period (estimated 1 hour post sedation)
Primary outcome [2] 297558 0
Minor airway complications, such as:
Apnoea (cesation in respirations for >20 seconds),
laryngospasm,(acute onset of short lived stridorous inspiratory sounds)
O2 desaturation,(via pulse oximitry)
hypersalivation, (excessive salivation manifest by drooling of saliva)
minor airway interventions performed in ED during sedative episode (Chin lift, jaw thrust, Assisted ventilation) all are clinical actions and will be recorded as occurrring if they are performed
Timepoint [2] 297558 0
During ED visit, in sedative period, (usually 45 minutes or so from start point of sedation) and the immediate recovery period (estimated 1 hour post sedation)
Primary outcome [3] 297559 0
Other non-airway complications related to the sedation episode, the patient will be observed by the medical officer for complications, these will be recorded on a prospective data collection tool, if complications occurr (as per standard practice during ED sedation or anaesthesia):
vomiting, (noted if it occurrs) as per standard practice during ED sedation or anaesthesia
emergence delirium (combative, excited, or agitated behaviour requiring transient physical or chemical restraint), as per standard practice during ED sedation or anaesthesia
hyper- or hypo-tension, given the wide range of patient ages and deviation of systolic blood pressure by 30% either above baseline (hypertension) or 20% below baseline (hypotension). Blood pressure will be measured using an automated sphygmomanometer as per standard practice during ED sedation or anaesthesia
Timepoint [3] 297559 0
During ED visit, in sedative period, (usually 45 minutes or so from start point of sedation) and the immediate recovery period (estimated 1 hour post sedation)
Secondary outcome [1] 320882 0
Composite secondary outcome. Post-discharge follow-up for post-discharge effects of sedative medications given in ED. Assessed using a questionnaire designed specifically for this study. Asessed by patient repsonse at telephone interview.
Assessed for:
Vomiting post discharge from the ED
Awareness during sedative episode
Memory of pain occurring during sedative episode
Ongoing pain at IV cannula site
Motor unsteadiness or incoordination post discharge
Timepoint [1] 320882 0
Patients will be followed up by phone between 1 and 6 weeks post discharge from the ED. Patients who are unable to be contacted during this 1-6 week time frame will have phone contact attempts made for up to 3 months. After this point, if still uncontactable, patients willbe deemed lost to follow-up. Hence the 3 month time limit.
Secondary outcome [2] 320883 0
Procedure related complications, will be based on the procedure performed. If the procedure performed is a fracture reduction, then successful healing of the fracture or review in fracture clinic with no requirement for further intervention would be a secondary outcome. Similarly if sedation was for wound exploration for removal of a deep foreign body, and repair, then outcome would be successful healing of the wound, or wound review that led to no further intervention. Assesed on phone follow-up
Timepoint [2] 320883 0
Patients will be followed up by phone between 1 and 6 weeks post discharge from the ED. Patients who are unable to be contacted during this 1-6 week time frame will have phone contact attempts made for up to 3 months. After this point, if still uncontactable, patients willbe deemed lost to follow-up

Eligibility
Key inclusion criteria
patients requiring procedural sedation in ED
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent to data collection and follow-up
Unwilling to consent to data collection and follow-up
Senior clinician must be present in the ED to oversee sedation

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/03/2015
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20000
Accrual to date
2135
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5285 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [2] 5286 0
Mater Adult Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 292902 0
Self funded/Unfunded
Name [1] 292902 0
nill
Country [1] 292902 0
Primary sponsor type
Individual
Name
Dr Adam Michael
Address
Emergency Department
Bundaberg Hospital
Bourbong St Bundaberg 4670
Queensland
Country
Australia
Secondary sponsor category [1] 291648 0
Individual
Name [1] 291648 0
Dr Greg Treston
Address [1] 291648 0
Emergency Department
Mater Hospital Brisbane
Stanley St
South Brisbane 4101
Queensland
Country [1] 291648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294402 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 294402 0
Ethics committee country [1] 294402 0
Australia
Date submitted for ethics approval [1] 294402 0
12/02/2013
Approval date [1] 294402 0
25/06/2014
Ethics approval number [1] 294402 0
HREC/14/QGC/40

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

Contacts
Principal investigator
Name 63610 0
Dr Adam Michael
Address 63610 0
Emergency Department
Bundaberg Hospital
Bourbong St
Bundaberg
4670
Queensland
Country 63610 0
Australia
Phone 63610 0
+61741502220
Fax 63610 0
Email 63610 0
[email protected]
Contact person for public queries
Name 63611 0
Adam Michael
Address 63611 0
Emergency Department
Bundaberg Hospital
Bourbong St
Bundaberg
4670
Qld
Country 63611 0
Australia
Phone 63611 0
+61741502220
Fax 63611 0
Email 63611 0
[email protected]
Contact person for scientific queries
Name 63612 0
Adam Michael
Address 63612 0
Emergency Department
Bundaberg Hospital
Bourbong St
Bundaberg
4670
Qld
Country 63612 0
Australia
Phone 63612 0
+61741502220
Fax 63612 0
Email 63612 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?




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.