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Trial registered on ANZCTR


Registration number
ACTRN12611001121954
Ethics application status
Approved
Date submitted
25/10/2011
Date registered
27/10/2011
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective randomised trial comparing Parker tip and Magill tip endotracheal tubes for cricothyroidotomy
Scientific title
Prospective randomised trial of anaesthetists comparing Parker tip and Magill tip endotracheal tubes for insertion into the trachea over a bougie.
Secondary ID [1] 273265 0
none
Universal Trial Number (UTN)
U1111-1125-4337
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cricothyroidotomy 279031 0
Condition category
Condition code
Anaesthesiology 279217 279217 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emergency cricothyroidotomy using a scalpel bougie endotracheal tube technique will be performed. This technique involves a transverse stab incision through the skin and cricothyroid membrane or trachea. Once inserted, the scalpel is rotated 90 degrees creating a triangular hole through which a bougie can be inserted down the trachea. This bougie is then used to railroad an endotracheal tube. This trial will compare the Magill tip (firm) and the Parker tip (soft) endotracheal tubes. Three anaesthetists will perform this procedure on 9 cadavers, and will use equal numbers of Magill or Parker tip tubes in a randomised fashion using a crossover design. Each cadaver will be used three times, with one cricothyroid and two tracheal incisions resulting in a total of 27 procedures.
Intervention code [1] 269608 0
Treatment: Surgery
Comparator / control treatment
Traditional Magill tip endotracheal tube versus the newer designed Parker tip endotracheal tube. The Magill has a firm leading edge which is angled at approximately 60 degrees. The Parker tip has a soft atraumatic tip which is designed to fold and then re-form following intubation.
Control group
Active

Outcomes
Primary outcome [1] 279850 0
Time to insert the endotracheal tube (ETT) through a scalpel incision in a cadavers neck into the trachea.
Timepoint [1] 279850 0
From the time the tip of the ETT touches the skin surface, until the tube has advanced into the trachea.
Secondary outcome [1] 294577 0
Length of tube and bougie advancement.
Timepoint [1] 294577 0
Centimeters. This outcome will be measured at the end of the procedure.

Eligibility
Key inclusion criteria
Specialist anaesthetists of at least two years experience
Minimum age
30 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Completed previous training or performed a cricothyroidotomy in the last two years.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will volunteer for the study following an advertisement placed on the departmental notice board. Subjects will need to comply with the inclusion criteria.
The order will be placed into 27 sealed envelopes and opened by the anaesthetic assistant immediately prior to use. Once selected, it is not possible to hide the tip design from the participants or the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Magill or Parker tubes will be used in a random order using computer generated randomisation (GraphPad Software Registered Trademark Inc, La Jolla, California, USA).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Every anaesthetist will perform a total of 3 procedures on each of the 9 cadavers.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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 outside Australia
Country [1] 3926 0
New Zealand
State/province [1] 3926 0

Funding & Sponsors
Funding source category [1] 284096 0
Self funded/Unfunded
Name [1] 284096 0
Paul Baker
Address [1] 284096 0
Department of Anaesthesiology,
The University of Auckland,
Level 12, Support Building, Auckland City Hospital,
Park Road, Grafton,
Private bag 92019
Auckland 1142, New Zealand.
Country [1] 284096 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The Department of Anaesthesiology,
Faculty of Medical and Health Science,
The University of Auckland,
Private Bag 92019,
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 269058 0
Government body
Name [1] 269058 0
Hospital
Address [1] 269058 0
Auckland City Hospital,
Starship Children's Health,
Private Bag 92024
Park Road, Grafton,
Auckland 1142
Country [1] 269058 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272046 0
Northern X Regional Ethics Committee
Ethics committee address [1] 272046 0
Private Bag 92522,
Wellesley Street,
Auckland 1141
Ethics committee country [1] 272046 0
New Zealand
Date submitted for ethics approval [1] 272046 0
06/10/2011
Approval date [1] 272046 0
17/10/2011
Ethics approval number [1] 272046 0
NTX/11/EXP/241

Summary
Brief summary
The aim of this study is to simulate cricothyroidotomy using two different types of endotracheal tube, a Magill (rigid) tip and a Parker (soft) tip. The procedure is called a Scalpel bougies technique, where a scalpel stab incision is made through the skin over the cricothyroid membrane. A bougie ( a long hollow tube guide) is inserted through this incision into the treachea, and an endotracheal tube is then advanced over the bougie into the trachea. This endotracheal tube is used to administer life saving oxygen. This technique is only used in an extreme emergency when a patients airway has obstructed, and a doctor is unable to ventilate or intubate any other way. The procedure will be performed on cadavers, and the participants will be specialists anaesthetists. The study will be a prospective randomised controlled trial.
Trial website
Trial related presentations / publications
Publication enclosed
Public notes
Attachments [1] 2880 2880 0 0

Contacts
Principal investigator
Name 33306 0
Dr Paul Baker
Address 33306 0
21A Ranui Road, Remuera, Auckland 1050, New Zealand
Country 33306 0
New Zealand
Phone 33306 0
+6495246478
Fax 33306 0
Email 33306 0
paul@airwayskills.co.nz
Contact person for public queries
Name 16553 0
Dr Dr Paul Baker
Address 16553 0
Department of Anaesthesiology,
Level 12, Support Building, Auckland City Hospital,
2 Park Road, Grafton
The University of Auckland,
Private Bag 92019,
Auckland 1142
Country 16553 0
New Zealand
Phone 16553 0
0064 9 9239300
Fax 16553 0
0064 9 3737970
Email 16553 0
p.baker@auckland.ac.nz
Contact person for scientific queries
Name 7481 0
Dr Dr Paul Baker
Address 7481 0
Department of Anaesthesiology,
Level 12, Support Building, Auckland City Hospital,
2 Park Road, Grafton
The University of Auckland,
Private Bag 92019,
Auckland 1142
Country 7481 0
New Zealand
Phone 7481 0
0064 9 9239300
Fax 7481 0
0064 9 3737970
Email 7481 0
p.baker@auckland.ac.nz

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary