Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001591448
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
17/11/2016
Date last updated
31/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the return of pulsatile flow by carotid artery ultrasound using cardiac bypass patients as a model of the return of spontaneous circulation
Scientific title
Assessment of the return of pulsatile flow by carotid artery two-dimension or colourDoppler ultrasound using cardiac bypass patients as a model for the return of spontaneous circulation: A Pilot study
Secondary ID [1] 290496 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 300886 0
Condition category
Condition code
Cardiovascular 300703 300703 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an interventional trial with two arms. The trial will evaluate the use of US to detect pulsatile flow compared to the blood pressure as measured on the radial arterial line. The participants will be randomised to 2D US or colour-Doppler. One of the investigators will ultrasound the carotid artery of patients as they come off bypass and a video of the image recorded. At the same time a video will be recorded of the anaesthetic monintor. Three Independent investigators will assess the ultrasound images and will record the time at which they think sustained pulsatile flow occurs, This will then be correlated to the blood presssure of the participants. Those assessing the ultrasound images will not have access to the monitor videos. The assessors will be three anaesthetists (two cardiac and one general anaesthetist). Videos will be recorded as rewarming of the heart begins and continue for approximately 5 minutes after the return of spontaneous circulation
Intervention code [1] 296353 0
Diagnosis / Prognosis
Comparator / control treatment
participants are randomised to receive either 2D or colour-Doppler US at the time of coming off bypass.
Control group
Active

Outcomes
Primary outcome [1] 300125 0
The ptimary outcome is the agreement between assessors as to the time of return of pulsatile flow on 2D and colourDoppler ultrasound assessed by interrelator agreement
Timepoint [1] 300125 0
time of the detection of pulsatile flow
Secondary outcome [1] 329112 0
The secondary outcome will be the MAP when pulsatile flow first detected by 2d or colourDoppler by inter-relator agreement.
Timepoint [1] 329112 0
Time when pulsatile flow visible on arterial line trace

Eligibility
Key inclusion criteria
Age > 18. Ability to offer informed consent. Undergoing cardiac surgery requiring cardiac bypass from the perfusion machine.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery involving the great blood vessels including aorta or carotid arteries. Patients in whom the cardiac surgeon considers enrolment will be inappropriate due to high surgical risk, patients with intraaortic balloon pump, known peripheral vascular disease.

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)
Central allocation to 2D or colour Doppler at time of study design
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Random sequence generation using software R
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be performed using R statistical software version 3.1.2 (2014-10-31).

Participant demographics will be reported as mean plus or minus standard deviation, whilst non-normal data will be reported as median plus interquartile range. Categorical data will be reported as counts and proportions. 2D US and colour-flow Doppler groups will be compared using non-parametric methods due to the small sample size.

As only twenty participants are intended to be enrolled in total, the blood pressure data will be considered non-normal. SBP and MAP will be reported as median plus interquartile range for 2D US and colour-flow doppler US.

In the first analysis, a measure of inter-rater agreement will be calculated for the time when pulsatile flow is first calculated. An interclass correlation coefficient and limits of agreement will be calculated from the data for the 2D and colour flow Doppler methods.

The second anaylsis will compare the difference in arterial blood pressure when pulsatile flow is first detected by 2D US and colour-flow Doppler. Firstly, a median SBP and MAP will be calculated for the three assessor estimates for each participant. These will then be compared using interclass correlation coefficient.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
5/12/2016
Actual
23/01/2017
Date of last data collection
Anticipated
10/12/2016
Actual
27/01/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6906 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 14574 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 294913 0
Hospital
Name [1] 294913 0
St George Hospital
Country [1] 294913 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Gray St, Kogarah NSW 2217, Australia
Country
Australia
Secondary sponsor category [1] 293747 0
None
Name [1] 293747 0
Address [1] 293747 0
Country [1] 293747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296291 0
South Eastern Sydney Local Health District
Ethics committee address [1] 296291 0
Ethics committee country [1] 296291 0
Australia
Date submitted for ethics approval [1] 296291 0
23/11/2015
Approval date [1] 296291 0
24/02/2016
Ethics approval number [1] 296291 0
HREC/15/POWH/579

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70290 0
Dr Matthew Miller
Address 70290 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada
Country 70290 0
Canada
Phone 70290 0
+447521046880
Fax 70290 0
Email 70290 0
[email protected]
Contact person for public queries
Name 70291 0
Matthew Miller
Address 70291 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada
Country 70291 0
Canada
Phone 70291 0
+447521046880
Fax 70291 0
Email 70291 0
[email protected]
Contact person for scientific queries
Name 70292 0
Matthew Miller
Address 70292 0
Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada
Country 70292 0
Canada
Phone 70292 0
+447521046880
Fax 70292 0
Email 70292 0
[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
SourceTitleYear of PublicationDOI
EmbaseThe reliability of carotid ultrasound in determining the return of pulsatile flow: A pilot study.2018https://dx.doi.org/10.1177/1742271X17753467
N.B. These documents automatically identified may not have been verified by the study sponsor.