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Trial registered on ANZCTR


Registration number
ACTRN12613001052729
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
20/09/2013
Date last updated
20/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australia and New Zealand Emergency Department
Airway Registry (ANZEDAR). A multi-centre observational study of the practice of intubation in the Emergency Department (ED)
Scientific title
Prospective, multicentre, observational study of all patients undergoing endotracheal intubation in the Emergency Department, to evaluate key metrics including indication for intubation, staff seniority, techniques, number of attempts at laryngoscopy required and the rate of intubation manoeuvres and complications.
Secondary ID [1] 282833 0
NIL
Universal Trial Number (UTN)
Trial acronym
ANZEDAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Injury 289620 0
Neck or Facial Trauma 289621 0
Burns/Inhalation
289622 0
Drowning 289623 0
Chest Trauma 289624 0
Shock due to trauma 289625 0
Traumatic Cardiac Arrest 289626 0
Respiratory Failure 289627 0
Airway obstruction 289628 0
Anaphylaxis 289629 0
Cardiac Failure 289630 0
Sepsis 289632 0
GI Bleed 289633 0
Seizure 289634 0
Stroke/ICH 289635 0
Altered mental status not due to overdose 289636 0
Overdose/Ingestion
289637 0
Cardiac Arrest 289638 0
Condition category
Condition code
Anaesthesiology 289958 289958 0 0
Anaesthetics
Public Health 290493 290493 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
less than 1 hour
Target follow-up type
Weeks
Description of intervention(s) / exposure
We will record the indication for intubation, staff seniority, techniques (eg induction drugs or type of laryngoscope, bougie or stylet use), number of attempts at laryngoscopy required and the rate of intubation manoevres and complications. The entire process usually lasts only a few minutes, however complications are relevant if they occur within 10 minutes.
Intervention code [1] 287525 0
Not applicable
Comparator / control treatment
Observational study of current practice only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290010 0
Pooled data will be used for a descriptive study of the practice of intubation in Australasian EDs, with particular emphasis on the following key areas: indication for intubation
Timepoint [1] 290010 0
Over 12 months at each site
Primary outcome [2] 290550 0
Intubation technique (equipment and drugs used)
Timepoint [2] 290550 0
12 months
Primary outcome [3] 290551 0
Complications resulting from intubation - including hypoxia (Oxygen saturation <93%), hypotension (requiring fluid bolus or vaso pressor agents), main stem bronchial intubation, airway trauma, vomiting, medication error or equipment failure. These are observed via clinical assessment, routine monitoring of vital signs or on chest Xray (in the case of main stem bronchial intubation). They should occur within 10 minutes of intubation in order to be reported.
Timepoint [3] 290551 0
12 months
Secondary outcome [1] 303768 0
Can ED physicians predict difficulty of laryngoscopy? - one question s was laryngoscopy predicted to be difficult? (Y/N) - this can be compared to grade of view obtained and number of attempts required to intubate.
Timepoint [1] 303768 0
12 months
Secondary outcome [2] 303769 0
Identify behaviours towards failed intubation at different experience levels – eg SRMO/REG/CMO/Specialist. What do more senior doctors change for repeated attempts, eg technique/ laryngoscope/ patient position for a second attempt, in comparison to more junior staff?
Timepoint [2] 303769 0
12 months
Secondary outcome [3] 303770 0
Change in rates of complication (as defined in primary outcomes) reference to pre-oxygenation techniques, drugs and patient positioning.
Timepoint [3] 303770 0
12 months
Secondary outcome [4] 303771 0
Impact of manual in-line stabilisation/cricoid pressure/bougie on success - do these techniques affect first pass success rate? This will be observed and recorded at the time
Timepoint [4] 303771 0
12 months
Secondary outcome [5] 303772 0
Use of a pre-RSI checklist - this is marked as Y/N on the data form and its use will be compared to incidence of multiple attempts at intubation and the rate of occurrence of complications
Timepoint [5] 303772 0
12 months

Eligibility
Key inclusion criteria
All patients requiring endotracheal intubation in the ED
Minimum age
No limit
Maximum age
No limit
Gender
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
All patients who are requiring endotracheal intubation in participating EDs over a 12-month period will be enrolled. Experience at three tertiary EDs in Sydney suggests an average rate of 170 per year per ED. This equates to 2.6 intubations per 1000 presentations (actual values = 1.73, 2.33, 3.81). Indications for intubation due to trauma at these hospitals – all major trauma centres – comprised approximately 30% of the total. At an urban district hospital ED in Sydney, 35 intubations were recorded in one year – this institution has an annual census of 24,000. This yields an intubation rate of 1.5 per 1000 presentations.

All data will be entered into 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). chi squared test or, as appropriate, exact tests will be used to compare groups of categorical data and to test for trends. Logistic regression analysis using the direct method will be used to calculate the odds of success of intubation on first attempt. 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
Recruiting
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 1281 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 1282 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 1283 0
St George Hospital - Kogarah
Recruitment hospital [4] 1284 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 1285 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [6] 1286 0
Manly Hospital - Manly
Recruitment hospital [7] 1287 0
Orange Health Service - Orange
Recruitment hospital [8] 1288 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [9] 1289 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 1290 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [11] 1291 0
Maroondah Hospital - Ringwood East
Recruitment hospital [12] 1292 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [13] 1294 0
Gove District Hospital - Nhulunbuy
Recruitment hospital [14] 1295 0
Liverpool Hospital - Liverpool
Recruitment hospital [15] 1296 0
Broome Hospital - Broome
Recruitment hospital [16] 1297 0
Gladstone Hospital - Gladstone
Recruitment hospital [17] 1298 0
The Townsville Hospital - Douglas
Recruitment hospital [18] 1299 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [19] 1300 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [20] 1301 0
Western Hospital - Footscray
Recruitment hospital [21] 1304 0
The Prince Charles Hospital - Chermside
Recruitment hospital [22] 1305 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [23] 1306 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [24] 1307 0
Westmead Hospital - Westmead
Recruitment hospital [25] 1310 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [26] 1311 0
Cairns Base Hospital - Cairns
Recruitment hospital [27] 1312 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [28] 1313 0
Peel Health Campus - Mandurah
Recruitment hospital [29] 1314 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment outside Australia
Country [1] 5193 0
New Zealand
State/province [1] 5193 0

Funding & Sponsors
Funding source category [1] 287615 0
Government body
Name [1] 287615 0
The Emergency Care Institute
Address [1] 287615 0
Level 4, Sage Building, 67 Albert Avenue,
Chatswood NSW 2067
Country [1] 287615 0
Australia
Primary sponsor type
Individual
Name
Toby Fogg
Address
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 286359 0
None
Name [1] 286359 0
Address [1] 286359 0
Country [1] 286359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289586 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 289586 0
Research Office Level 13, Kolling Building Royal North Shore Hospital Pacific Highway ST LEONARDS NSW 2065
Ethics committee country [1] 289586 0
Australia
Date submitted for ethics approval [1] 289586 0
Approval date [1] 289586 0
17/09/2012
Ethics approval number [1] 289586 0
LNR/12/HAWKE/306

Summary
Brief summary
Advanced airway management is an accepted core skill of Emergency Physicians in Australasia. Rapid Sequence INtubation (RSI) is, however, a high-risk procedure that has been shown to have an increased rate of severe complications – such as failed intubation, hypoxia, hypotension or surgical airway – when it takes place in the Emergency Department (ED) in comparison to the operating theatre. The recently published Fourth National Audit of Major Complications of Airway Management in the UK reviewed severe complications associated with airway management in the ED. The authors found that a large proportion of events occurred out of hours, without consultant supervision, or without the operators following standard airway management algorithms and “failing to plan for failure.”

Several studies have been published that describe the performance of intubation in the EDs of North America, UK, Korea and Japan, but to date, only a single centre study has been published from an Australian ED. This study, carried out at the Royal North Shore Hospital, prompted significant changes in the practice of intubation in that ED, along with an increased educational focus on the subject, in order to improve clinical management.

This current project is being led by Dr. Toby Fogg and Dr. John Vassiliadis from the Royal North Shore Hospital ED, as a collaborative research venture with other EDs across Australasia and the Emergency Care Institute in NSW. It is a surveillance study to acquire data on the practice of intubation in the ED in order to improve the quality of care associated with this procedure.
Trial website
www.airwayregistry.org.au
Trial related presentations / publications
Fogg T, Annesley N, Hitos K, Vassiliadis J. Prospective observational study of the practice of endotracheal intubation in the emergency department of a tertiary hospital in Sydney, Australia. Emergency Medicine Australasia. 2012 Dec 6;24(6):617–624.
Public notes

Contacts
Principal investigator
Name 41446 0
Dr Toby Fogg
Address 41446 0
Emergency Department,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country 41446 0
Australia
Phone 41446 0
+61 2 9926 7111
Fax 41446 0
Email 41446 0
tobyfogg@mac.com
Contact person for public queries
Name 41447 0
Dr Toby Fogg
Address 41447 0
Emergency Department,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country 41447 0
Australia
Phone 41447 0
+61 2 9926 7111
Fax 41447 0
Email 41447 0
tobyfogg@mac.com
Contact person for scientific queries
Name 41448 0
Dr Toby Fogg
Address 41448 0
Emergency Department,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country 41448 0
Australia
Phone 41448 0
+61 2 9926 7111
Fax 41448 0
Email 41448 0
tobyfogg@mac.com

No information has been provided regarding IPD availability
Summary results
No Results