ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

NIL

Universal Trial Number (UTN)

Trial acronym

ANZEDAR

Linked study record

Health condition

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

Head Injury

Neck or Facial Trauma

Burns/Inhalation

Drowning

Chest Trauma

Shock due to trauma

Traumatic Cardiac Arrest

Respiratory Failure

Airway obstruction

Anaphylaxis

Cardiac Failure

Sepsis

GI Bleed

Seizure

Stroke/ICH

Altered mental status not due to overdose

Overdose/Ingestion

Cardiac Arrest

Condition category

Condition code

Anaesthesiology

Anaesthetics

Public Health

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]

Not applicable

Comparator / control treatment

Observational study of current practice only

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Over 12 months at each site

Primary outcome [2]

Intubation technique (equipment and drugs used)

Timepoint [2]

12 months

Primary outcome [3]

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]

12 months

Secondary outcome [1]

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]

12 months

Secondary outcome [2]

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]

12 months

Secondary outcome [3]

Change in rates of complication (as defined in primary outcomes) reference to pre-oxygenation techniques, drugs and patient positioning.

Timepoint [3]

12 months

Secondary outcome [4]

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]

12 months

Secondary outcome [5]

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]

12 months

Eligibility

Key inclusion criteria

All patients requiring endotracheal intubation in the ED

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

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

1/07/2013

Actual

Date of last participant enrolment

Anticipated

1/07/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

2500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [3]

St George Hospital - Kogarah

Recruitment hospital [4]

Prince of Wales Hospital - Randwick

Recruitment hospital [5]

Mona Vale Hospital - Mona Vale

Recruitment hospital [6]

Manly Hospital - Manly

Recruitment hospital [7]

Orange Health Service - Orange

Recruitment hospital [8]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [9]

Royal Hobart Hospital - Hobart

Recruitment hospital [10]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [11]

Maroondah Hospital - Ringwood East

Recruitment hospital [12]

The Royal Childrens Hospital - Parkville

Recruitment hospital [13]

Gove District Hospital - Nhulunbuy

Recruitment hospital [14]

Liverpool Hospital - Liverpool

Recruitment hospital [15]

Broome Hospital - Broome

Recruitment hospital [16]

Gladstone Hospital - Gladstone

Recruitment hospital [17]

The Townsville Hospital - Douglas

Recruitment hospital [18]

Rockingham General Hospital - Cooloongup

Recruitment hospital [19]

Fremantle Hospital and Health Service - Fremantle

Recruitment hospital [20]

Western Hospital - Footscray

Recruitment hospital [21]

The Prince Charles Hospital - Chermside

Recruitment hospital [22]

Calvary Mater Newcastle - Waratah

Recruitment hospital [23]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [24]

Westmead Hospital - Westmead

Recruitment hospital [25]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [26]

Cairns Base Hospital - Cairns

Recruitment hospital [27]

Wagga Wagga Base Hospital - Wagga Wagga

Recruitment hospital [28]

Peel Health Campus - Mandurah

Recruitment hospital [29]

Hornsby Ku-ring-gai Hospital - Hornsby

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The Emergency Care Institute

Address [1]

Level 4, Sage Building, 67 Albert Avenue,
Chatswood NSW 2067

Country [1]

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]

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

Ethics committee address [1]

Research Office Level 13, Kolling Building Royal North Shore Hospital Pacific Highway ST LEONARDS NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/09/2012

Ethics approval number [1]

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

Dr Toby Fogg

Address

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

Country

Australia

Phone

+61 2 9926 7111

Fax

[email protected]

Contact person for public queries

Name

Toby Fogg

Address

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

Country

Australia

Phone

+61 2 9926 7111

Fax

[email protected]

Contact person for scientific queries

Name

Toby Fogg

Address

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

Country

Australia

Phone

+61 2 9926 7111

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Emergency airway management in Australian and New Zealand emergency departments: A multicentre descriptive study of 3710 emergency intubations.	2017	https://dx.doi.org/10.1111/1742-6723.12815
Embase	Paediatric intubation in Australasian emergency departments: A report from the ANZEDAR.	2020	https://dx.doi.org/10.1111/1742-6723.13416
Embase	Apnoeic oxygenation was associated with decreased desaturation rates during rapid sequence intubation in multiple Australian and New Zealand emergency departments.	2021	https://dx.doi.org/10.1136/emermed-2019-208424

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically