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Trial registered on ANZCTR


Trial ID
ACTRN12611000587909
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
7/06/2011
Date last updated
3/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rapid sequence intubation in the Emergency Department: Is cricoid pressure nothing more than a pain in the neck?
Scientific title
A randomised controlled trial of the efficacy of standard versus measured cricoid force in preventing aspiration in patients intubated in the Emergency Department.
Secondary ID [1] 262317 0
None
Universal Trial Number (UTN)
U1111-1121-9716
Trial acronym
ANSWER (Amalgamated New South Wales Emergency Research) Cricoid Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cricoid pressure and aspiration in emergency intubations. 268027 0
Condition category
Condition code
Respiratory 268156 268156 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A force of 30-40N is applied to the patient's cricoid during intubation. This is achieved by the cricoid operator standing on a platform scale and reducing their weight on the scales by 3.060 - 4.075 kg while applying pressure to the patient's cricoid. A data recorder records weight data for later analysis by the researchers. Once successful intubation is confirmed by end-tidal CO2, aspirates will be suctioned from the oropharynx and trachea. the aspirates will be tested for the presence of pepsin. The patient's records will be reviewd at 28 days to determine whether they were treated for aspiration pneumonitis.
Intervention code [1] 266710 0
Treatment: Devices
Comparator / control treatment
The cricoid operator stands on a platform scale but is blinded to the change in their weight during application of cricoid pressure (scale display panel is covered). The amount of cricoid applied during intubation is that which the operator would normally apply (what they believe to be the correct amount of force). A data recorder records weight data for later analysis by the researchers.
Once successful intubation is confirmed by end-tidal CO2, aspirates will be suctioned from the oropharynx and trachea. the aspirates will be tested for the presence of pepsin. The patient's records will be reviewd at 28 days to determine whether they were treated for aspiration pneumonitis.
Control group
Active

Outcomes
Primary outcome [1] 266901 0
Aspiration rate determined by the presence of pepsin in the trachea and/or if the patient is treated for aspiration pneumonia up to 28 days post-intubation.
Timepoint [1] 266901 0
24 hours (pepsin assay) and 28 days post-intervention (follow-up from patient records).
Secondary outcome [1] 276589 0
Incidence of failed intubation (termination of the attempt at rapid sequence inutbation, use of laryngeal mask or surgical airway).
Timepoint [1] 276589 0
At intervention.
Secondary outcome [2] 276594 0
Ease of intubation, determined by: the number of attempts required to place ETT, prolonged intubation (>10 mins.) using conventional laryngosopy or a required change in operator.
Timepoint [2] 276594 0
At intervention.
Secondary outcome [3] 276596 0
Grade of laryngoscopic view obtained using the Modified system (1, 2a, 2b, 3 or 4).
Timepoint [3] 276596 0
At intervention.

Eligibility
Key inclusion criteria
All adult patients presenting to the Emergency Department requiring intubation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing CPR.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Any adult patient requiring emergency intubation (but not receiving CPR) will be eligible for enrolment into the trial. Informed consent will be sought from the Person Responsible at the time of consent. Patients will be randomly assigned to one of the study groups when the cricoid operator opens a trial enrolment pack containing the group allocation. The packs are identical are appearance therefore the group assignment is not apparent to the operator until it has been opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 267194 0
University
Name [1] 267194 0
University Department of Rural Health, University of Newcastle
Address [1] 267194 0
Locked bag 9783
NEMSC
Tamworth
NSW 2348
Country [1] 267194 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Trethewy
Address
Tamworth Rural Referral Hospital
Johnston St
Tamworth
NSW 2340
Country
Australia
Secondary sponsor category [1] 266266 0
None
Name [1] 266266 0
Address [1] 266266 0
Country [1] 266266 0
Other collaborator category [1] 252040 0
University
Name [1] 252040 0
University Department of Rural Health, University of Newcastle
Address [1] 252040 0
Locked bag 9783
NEMSC
Tamworth
NSW 2348
Country [1] 252040 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269186 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 269186 0
Hunter New England Health
Locked bag 1
New Lambton
NSW 2305
Ethics committee country [1] 269186 0
Australia
Date submitted for ethics approval [1] 269186 0
Approval date [1] 269186 0
24/02/2010
Ethics approval number [1] 269186 0
06/11/22/4.03

Summary
Brief summary
The ANSWER Cricoid Trial is a randomised controlled study to determine whether the use of cricoid pressure is effective in prevention of aspiration during emergency intubations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32701 0
Address 32701 0
Country 32701 0
Phone 32701 0
Fax 32701 0
Email 32701 0
Contact person for public queries
Name 15948 0
Dr Julie Burrows
Address 15948 0
University Department of Rural Health
University of Newcastle
Locked bag 9783
NEMSC
Tamworth
NSW 2348
Country 15948 0
Australia
Phone 15948 0
+61 2 6767 8477
Fax 15948 0
+61 2 6761 2355
Email 15948 0
julie.burrows@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 6876 0
Dr Chris Trethewy
Address 6876 0
Tamworth Rural Referral Hospital
Johnston Street
Tamworth
NSW 2340
Country 6876 0
Australia
Phone 6876 0
+61 2 6767 7700
Fax 6876 0
Email 6876 0
christopher.trethewy@hnehealth.nsw.gov.au