ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Cardiac Arrest

Condition category

Condition code

Cardiovascular

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]

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]

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]

time of the detection of pulsatile flow

Secondary outcome [1]

The secondary outcome will be the MAP when pulsatile flow first detected by 2d or colourDoppler by inter-relator agreement.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Hospital - Kogarah

Recruitment postcode(s) [1]

2217 - Kogarah

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St George Hospital

Address [1]

Gray St, Kogarah NSW 2217, Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

St George Hospital

Address

Gray St, Kogarah NSW 2217, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District

Ethics committee address [1]

Research Support Office
G71, East Wing 
Edmund Blacket Building
Prince of Wales Hospital
Barker St
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/11/2015

Approval date [1]

24/02/2016

Ethics approval number [1]

HREC/15/POWH/579

Summary

Brief summary

Current cardiac arrest algorithms require assessment of the return of spontaneous circulation (ROSC) following rhythm checks. Current recommendations for assessment of ROSC include observation for patient movement or spontaneous respiration, both of which may be absent in sedated and paralysed patients. Healthcare professionals are advised to check the pulse in the presence of an organized rhythm, however previous studies have shown poor ability to correctly   detect the presence or absence of a pulse in a simulated pulseless electrical activity (PEA) arrest. In one study, 45% of participants incorrectly diagnosed pulselessness in cardiac surgery patients no longer on bypass, despite systolic pressures greater than 80mmHg.  

In coronary artery bypass graft (CABG) surgery, when coming off bypass, blood flow changes from continuous to pulsatile. This may offer a model by which to simulate the return of pulsatile flow, and allow a comparison of radial arterial pressures when pulsatile flow becomes first apparent on 2D US and colour flow Doppler US of the carotid artery. This pilot study proposes to investigate whether pulsatile flow can be reliably assessed by the use of carotid artery ultrasound, and whether CABG patients can be used as a model to evaluate this.

Trial website

Trial related presentations / publications

Published in Ultrasound : 
Biljana Germanoska, Matthew Coady, Sheyin Ng, Gary Fermanis, Matthew MillerThe reliability of carotid ultrasound in determining the return of pulsatile flow: A pilot study. Ultrasound 
epub ahead of print January 29, 2018
https://doi.org/10.1177/1742271X17753467

Public notes

Contacts

Principal investigator

Name

Dr Matthew Miller

Address

Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada

Country

Canada

Phone

+447521046880

Fax

mattdotmiller@gmail.com

Contact person for public queries

Name

Matthew Miller

Address

Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada

Country

Canada

Phone

+447521046880

Fax

mattdotmiller@gmail.com

Contact person for scientific queries

Name

Matthew Miller

Address

Department of Anaesthesia
Toronto Western Hospital,
399 Bathurst St,
Toronto,
ON M5T 2S8,
Canada

Country

Canada

Phone

+447521046880

Fax

mattdotmiller@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	The reliability of carotid ultrasound in determining the return of pulsatile flow: A pilot study.	2018	https://dx.doi.org/10.1177/1742271X17753467

N.B. These documents automatically identified may not have been verified by the study sponsor.

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