Trial Review

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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] 291733 0
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 302949 0
Cannot intubate, cannot oxygenate 302950 0
Cricothyroidotomy 302951 0
Condition category
Condition code
Anaesthesiology 302418 302418 0 0
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] 297855 0
Diagnosis / Prognosis
Intervention code [2] 297866 0
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] 301849 0
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] 301849 0
At the time of CT scan
Secondary outcome [1] 334041 0
Time from commencement to final placement of marker for ultrasound or landmark technique.
Timepoint [1] 334041 0
At time of CT imaging.
Secondary outcome [2] 334042 0
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] 334042 0
At time of CT imaging
Secondary outcome [3] 334205 0
Clinician confidence in the accuracy of marker placement for ultrasound or landmark technique (on a 10- point numerical rating scale).
Timepoint [3] 334205 0
At time of CT imaging
Secondary outcome [4] 334206 0
Clinician preference for ultrasound or landmark technique (on a 10- point numerical rating scale).
Timepoint [4] 334206 0
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?
No
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
62
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7883 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 15828 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 296230 0
Hospital
Name [1] 296230 0
Liverpool Hospital
Country [1] 296230 0
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] 295147 0
None
Name [1] 295147 0
Address [1] 295147 0
Country [1] 295147 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297469 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 297469 0
Ethics committee country [1] 297469 0
Australia
Date submitted for ethics approval [1] 297469 0
14/11/2016
Approval date [1] 297469 0
02/03/2017
Ethics approval number [1] 297469 0
HREC/16/LPOOL/635

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1653 1653 0 0
/AnzctrAttachments/372771-Cricothyroid ultrasound protocol V6.pdf (Protocol)
Attachments [2] 1654 1654 0 0
/AnzctrAttachments/372771-Letter - REO - HE16 337 - Approval - Ethics 1-signed.pdf (Ethics approval)
Attachments [3] 1655 1655 0 0
/AnzctrAttachments/372771-CRICUS PIS V3.0.pdf (Participant information/consent)
Attachments [4] 1656 1656 0 0
/AnzctrAttachments/372771-Training Protocol - Ultrasound-guided Localisation of the Cricothyroid Membrane .pdf (Supplementary information)

Contacts
Principal investigator
Name 74142 0
Dr Christopher Partyka
Address 74142 0
Emergency Department
Liverpool Hospital (South Western Sydney Local Health District)
Locked Bag 7103
Liverpool BC NSW 1871
Country 74142 0
Australia
Phone 74142 0
+61 2 8738 3950
Fax 74142 0
+61 2 8738 3984
Email 74142 0
[email protected]
Contact person for public queries
Name 74143 0
Christopher Partyka
Address 74143 0
Emergency Department
Liverpool Hospital (South Western Sydney Local Health District)
Locked Bag 7103
Liverpool BC NSW 1871
Country 74143 0
Australia
Phone 74143 0
+61 2 8738 3950
Fax 74143 0
+61 2 8738 3984
Email 74143 0
[email protected]
Contact person for scientific queries
Name 74144 0
Christopher Partyka
Address 74144 0
Emergency Department
Liverpool Hospital (South Western Sydney Local Health District)
Locked Bag 7103
Liverpool BC NSW 1871
Country 74144 0
Australia
Phone 74144 0
+61 2 8738 3950
Fax 74144 0
+61 2 8738 3984
Email 74144 0
[email protected]

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.