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Trial registered on ANZCTR


Registration number
ACTRN12619000607178
Ethics application status
Approved
Date submitted
12/04/2019
Date registered
23/04/2019
Date last updated
18/08/2020
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
18/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Should we CHECK it? Assessing interrogation of cardiac implantable electronic devices in the Emergency Department
Scientific title
Should we CHECK it? Assessing interrogation of Cardiac Implantable Electronic Devices (CIEDs) in the Emergency Department; implications for service planning and care delivery.
Secondary ID [1] 297993 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CHECK-ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrhythmia Management 312349 0
cardiac implantable electronic devices 312381 0
Condition category
Condition code
Cardiovascular 310937 310937 0 0
Other cardiovascular diseases
Emergency medicine 310979 310979 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention/exposure. This is a retrospective audit study which will review all Cardiac Implanted Electronic Device checks performed in the Royal Adelaide Hospital Emergency Department over a defined twelve month period to assess how often these checks identify relevant clinical data for the each patient's presentation. The audit period will be 4th September 2016 to 3rd September 2017, inclusive.
Intervention code [1] 314191 0
Not applicable
Comparator / control treatment
No treatment intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319752 0
Incidence of Remarkable Issues (RI) for all checks performed in the ED over the audit period. The composite endpoint of "Remarkable Issues" is comprised of;
a) CIED malfunction which required urgent reprogramming (ie; lead dislodgment or battery issue), or;
b) Significant arrhythmia responsible for presentation, or;
d) Tachyarrhythmia therapy intervention since last device check (ie; AICD shock or Anti Tachycardia Pacing).
Timepoint [1] 319752 0
Retrospective Audit study of Hospital medical records over 12month period (4th September 2016 to 3rd September 2017, inclusive)
Secondary outcome [1] 369418 0
Burden of after-hours device checks performed in the ED. After Hours occasion of service is defined as;
a) CIED check being performed on occasions outside of 8am to 5pm during Monday to Friday.
Timepoint [1] 369418 0
Retrospective Audit study of Hospital medical records over 12month period (4th September 2016 to 3rd September 2017, inclusive).
Secondary outcome [2] 369419 0
Differential burden of Remarkable Issues (RI) for checks performed in the ED by device type. The CIED types consisting of;
a) Permanent Pacemaker (PPM).
b) Implanted Cardioverter Defibrillator (ICD).
c) Implanted Loop Recorder (ILR).
Timepoint [2] 369419 0
Retrospective Audit study of Hospital medical records over 12month period (4th September 2016 to 3rd September 2017, inclusive).

Eligibility
Key inclusion criteria
Inclusion in the audit will be evaluated by the following criteria:
a. The patient presented to the Royal Adelaide Hospital ED and had a CIED interrogation performed during ED admission.
b. The CIED was either a PPM, ICD or implanted Loop Recorder (ILR).
c. The CIED check was documented in the patient’s medical records.
d. At least 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
"None"

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
All data will be analyzed retrospectively. The nominal data will be presented as number of events (n) and percentage (%). Normally distributed continuous data will be expressed as mean ± standard deviation. The difference between groups will be analyzed using chi-squared comparisons for the nominal data and the normal continuous data tested with unpaired t-tests between groups. Clinical predictors of remarkable issues will be evaluated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13618 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 26283 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 302472 0
Self funded/Unfunded
Name [1] 302472 0
Nil
Address [1] 302472 0
Nil
Country [1] 302472 0
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace, ADELAIDE, SOUTH AUSTRALIA, 5000
Country
Australia
Secondary sponsor category [1] 302430 0
None
Name [1] 302430 0
Address [1] 302430 0
Country [1] 302430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303134 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 303134 0
Royal Adelaide Hospital
Port Road, ADELAIDE, SA 5000
Ethics committee country [1] 303134 0
Australia
Date submitted for ethics approval [1] 303134 0
26/03/2019
Approval date [1] 303134 0
10/04/2019
Ethics approval number [1] 303134 0
HREC/19/CALHN/162

Summary
Brief summary
The purpose of this study is to investigate the outcomes of Cardiac Implantable Electronic Device (CIED) interrogations performed in the Emergency Department (ED). Patients who present to the Royal Adelaide Hospital’s (RAH) ED whom have an Implanted Cardiac Electronic Device (CIED) currently have their device interrogated upon request by the attending ED physician. These device interrogations are performed by Cardiac Physiologists, often requiring call-backs at the expense of the hospital, who use specialised computer systems which can interact with the device by telemetry. The performance of the CIED can be assessed during these interrogations to exclude device malfunction as a contributing factor to the patient’s clinical presentation. Furthermore, clinical data trends stored in the device can assist in diagnostics for the ED physician. It is not known how frequently significant issues are detected from these device checks. We hypothesize that there is a low yield of significant issues identified by CIED checks performed in the ED. The outcomes of this study can be used to develop evidence-based triaging methods to reduce the number of unnecessary checks and call-backs being performed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92590 0
A/Prof Dennis Lau
Address 92590 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
Country 92590 0
Australia
Phone 92590 0
+61 8 8313 9000
Fax 92590 0
Email 92590 0
dennis.h.lau@adelaide.edu.au
Contact person for public queries
Name 92591 0
A/Prof Dennis Lau
Address 92591 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
Country 92591 0
Australia
Phone 92591 0
+61 8 8313 9000
Fax 92591 0
Email 92591 0
dennis.h.lau@adelaide.edu.au
Contact person for scientific queries
Name 92592 0
A/Prof Dennis Lau
Address 92592 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
Country 92592 0
Australia
Phone 92592 0
+61 8 8313 9000
Fax 92592 0
Email 92592 0
dennis.h.lau@adelaide.edu.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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary
Majority of Cardiac Implanted Electronic Device checks performed in the Emergency Department were negative for remarkable issues or events, although the incidence was greater for outside of office-hours checks and also for high voltage devices.