ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000612314

Ethics application status

Approved

Date submitted

24/04/2017

Date registered

28/04/2017

Date last updated

15/10/2019

Date data sharing statement initially provided

15/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Ultrasound or landmark for identification of the cricothyroid membrane.

Scientific title

Ultrasound versus landmark identification of the cricothyroid membrane in emergency department patients undergoing computed tomography of the cervical spine: a pilot randomised, single blind, clinical trial.

Secondary ID [1]

Nil known.

Universal Trial Number (UTN)

U1111-1195-7266

Trial acronym

CRICUS

Linked study record

N/A.

Health condition

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

Airway management

Cannot intubate, cannot oxygenate

Cricothyroidotomy

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study aims to compare the speed and accuracy of ultrasound versus landmark technique of identifying the cricothyroid membrane (CTM) and to secondarily assess the confidence of providers in the method that they have undertaken.

Patients will have their CTM identified via use of ultrasound immediately prior to undergoing routine CT imaging of the cervical spine. This will be performed by study staff (consultant emergency physicians or advanced trainees in emergency medicine, who have completed the training protocol and basic credentialing in emergency ultrasound, with at least eFAST and AAA competency). The CTM will marked by placement of a radiopaque marker and held in place using micropore tape. This will be removed at completion of the CT scan.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Patients will have their CTM identified via digital palpation and use of superficial landmarks prior to undergoing routine CT imaging of the cervical spine. This will be performed by study staff. The CTM will marked by placement of a radiopaque marker and held in place using micropore tape. This will be removed at completion of the CT scan.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome will be met if the centre of a radio-opaque marker is within the boundaries of the CTM as identified by computed tomography.

Timepoint [1]

At the time of CT scan

Secondary outcome [1]

Time from commencement to final placement of marker for ultrasound or landmark technique.

Timepoint [1]

At time of CT imaging.

Secondary outcome [2]

To determine if there is a significant difference in accuracy between ultrasound and landmark CTM identification in patients with a BMI greater than or equal to 25.

The accuracy of the technique will be assessed by calculating the percentage of patients in each group where the centre of the radio-opaque marker lies over any part of the cricothyroid membrane in the judgement of the assessing radiologists (who will be blinded to the technique used to place the marker).

Timepoint [2]

At time of CT imaging

Secondary outcome [3]

Clinician confidence in the accuracy of marker placement for ultrasound or landmark technique (on a 10- point numerical rating scale).

Timepoint [3]

At time of CT imaging

Secondary outcome [4]

Clinician preference for ultrasound or landmark technique (on a 10- point numerical rating scale).

Timepoint [4]

At time of CT imaging

Eligibility

Key inclusion criteria

Emergency department patients aged greater than or equal to 18 years, requiring computed tomography of the cervical spine for any indication.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

GCS <15, inability to provide informed consent, haemodynamic instability, anterior neck wound or cellulitis, Cervical spine injury excluded by use of clinical decision rule (ie. NEXUS or Canadian C- spine Rule).

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation will occur following the provision of informed consent, using an online randomisation tool, sealedenvelope.com.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A randomisation sequence will be generated using a computer generated randomisation tool. Sequentially numbered, opaque, tamper proof envelopes will be placed in a central location, and the next envelope in the sequence will be taken by the investigator following the provision of informed consent. Patients and operators will not be blinded to the treatment allocation, but the radiologist assessing the marker position will be blinded.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data from previous studies suggests that landmark technique identifies the CTM successfully in approximately 40% of patients, whereas ultrasound identifies it correctly in 80%.

Using a significance level of 0.05, and power of 80%, 28 patients are required in each arm; to allow for dropouts, a target of 31 patients in each arm (62 in total) is intended.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/06/2017

Actual

3/10/2017

Date of last participant enrolment

Anticipated

30/12/2019

Actual

Date of last data collection

Anticipated

27/01/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Liverpool Hospital

Address [1]

Goulburn St & Elizabeth St
Liverpool NSW 2170

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Christopher Partyka

Address

Emergency Department, Liverpool Hospital
Goulburn St & Elizabeth St
Liverpool NSW 2170

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SWSLHD Human Research Ethics Committee

Ethics committee address [1]

‘Research and Ethics Office’
Locked Bag 7103
LIVERPOOL BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/11/2016

Approval date [1]

02/03/2017

Ethics approval number [1]

HREC/16/LPOOL/635

Summary

Brief summary

A small number of patients who are brought to the emergency department need a general anaesthetic. This lets us help them by keeping their airway open and breathing for them, and allows us to perform tests and provide further treatment. In very rare cases, the breathing tube cannot be passed through the mouth. This is a life threatening emergency, and an emergency procedure called a cricothyroidotomy then has to be performed. This involves making a cut in the front of the neck, directly into the windpipe, so that the breathing tube can be put directly into the airway. This is similar to a tracheostomy.

The area of the neck where the cut is made is called the cricothyroid membrane, and it is usually identified by feeling the front of the neck with a finger. Recently, it has become clear that ultrasound scans can be used to locate the membrane, but it is not clear if this is more or less accurate than locating it by feel, and whether using an ultrasound takes more or less time.

The study aims to compare two groups of patients. One group will have their cricothyroid membrane identified by touch, and the other group will have it identified by ultrasound. The participants in the study, will be randomly assigned (like tossing a coin) into one of these two groups.

Immediately before having a CT scan, a doctor will try and locate the patients’ cricothyroid membrane using either touch or ultrasound (depending on the group they are randomised to), and then place a marker (a small metal cross) on the neck, which will be held in place with adhesive tape.

After the CT scan, an x-ray specialist will then be able to see whether or not the marker has been placed accurately. We will then compare whether one method is more accurate than the other, as well as how long it took to place the marker.

With the exception of (1) the attempt of cricothyroid membrane localisation, via ultrasound or landmark palpation and (2) placing a marker on their neck, the rest of the participants’ care will be carried out as normal.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372771-Cricothyroid ultrasound protocol V6.pdf (Protocol)

Attachments [2]

/AnzctrAttachments/372771-Letter - REO - HE16 337 - Approval - Ethics 1-signed.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/372771-CRICUS PIS V3.0.pdf (Participant information/consent)

Attachments [4]

/AnzctrAttachments/372771-Training Protocol - Ultrasound-guided Localisation of the Cricothyroid Membrane .pdf (Supplementary information)

Contacts

Principal investigator

Name

Dr Christopher Partyka

Address

Emergency Department
Liverpool Hospital (South Western Sydney Local Health District)
Locked Bag 7103
Liverpool BC NSW 1871

Country

Australia

Phone

+61 2 8738 3950

Fax

+61 2 8738 3984

Christopher.Partyka@sswahs.nsw.gov.au

Contact person for public queries

Name

Christopher Partyka

Address

Emergency Department
Liverpool Hospital (South Western Sydney Local Health District)
Locked Bag 7103
Liverpool BC NSW 1871

Country

Australia

Phone

+61 2 8738 3950

Fax

+61 2 8738 3984

Christopher.Partyka@sswahs.nsw.gov.au

Contact person for scientific queries

Name

Christopher Partyka

Address

Emergency Department
Liverpool Hospital (South Western Sydney Local Health District)
Locked Bag 7103
Liverpool BC NSW 1871

Country

Australia

Phone

+61 2 8738 3950

Fax

+61 2 8738 3984

Christopher.Partyka@sswahs.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

No additional documents have been identified.

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