ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000904178

Ethics application status

Approved

Date submitted

12/03/2019

Date registered

27/06/2019

Date last updated

2/03/2023

Date data sharing statement initially provided

27/06/2019

Date results provided

1/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Validity of pulsatile flow assessment by carotid artery ultrasound

Scientific title

Assessing the validity of two-dimensional ultrasound to detect the presence or absence of a pulse

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

Emergency medicine

Resuscitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Ten-second two-dimension ultrasound videos of the carotid artery at mean arterial pressure of 20-30mmHg, 40-50mmHg, 60-70 mmHg during cardiac surgery off bypass to be reviewed by critical care resident doctor

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The gold standard / comparator will be the presence of a pulse on an arterial line. When we collect the ultrasound images we will know if a pulse is present or not and this will be used to determine whether an video has a pulse or not, against which the physician-readers will be compared

Control group

Active

Outcomes

Primary outcome [1]

Specificity of carotid ultrasound to detect no pulse as assessed by detection of no pulse in patients not on bypass when compared to there also being no pulse on the arterial line, for the total sample

Timepoint [1]

in ten seconds

Primary outcome [2]

Sensitivity of carotid ultrasound to detect a pulse as assessed by detection of a pulse in patients not on bypass when compared to there also being a pulse on the arterial line for the total sample

Timepoint [2]

at 10 seconds

Secondary outcome [1]

a comparison of the specificity of carotid ultrasound to detect no pulse as assessed by detection of no pulse in patients not on bypass for each mean arterial pressure range (20-30mmHg, 40-50mmHg, 60-70 mmHg) compared to the presence / absence of a pulse on the arterial line, as assessed by Youdin's Index

Timepoint [1]

10 seconds

Secondary outcome [2]

a comparison of the sensitivity of carotid ultrasound to detect no pulse as assessed by detection of no pulse in patients not on bypass for each mean arterial pressure range (20-30mmHg, 40-50mmHg, 60-70 mmHg) compared to the presence / absence of a pulse on the arterial line, as assessed by Youdin's Index

Timepoint [2]

10 seconds

Eligibility

Key inclusion criteria

There will be two groups of participants:

1. Carotid ultrasound participants. These participants will be from consenting cardiac surgery volunteers. All cardiac surgery patients who will be placed on bypass during their surgery, including valve replacement or coronary artery bypass grafts. Age > 18. Ability to offer informed consent.

2. Critical care physician readers. These participants will be consenting volunteer critical care physicians who will be asked to review a maximum of 30 of the carotid ultrasound video clips. Any post-graduate critical care physician who uses ultrasound in their clinical practice, whether for focussed echocardiography, central line placement or trauma assessment.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Cardiac surgery participants: Previous surgery involving the great blood vessels including aorta or carotid arteries. Patients who the cardiac surgeon considers to be inappropriate due to a high surgical risk, patients with an intra-aortic balloon pump, and patients with known carotid artery stenosis.

Critical care physician readers: No previous experience with ultrasound.

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)

The randomisation will be the order in which the ultrasound scans are presented to the readers. Readers of the ultrasound scans will not know whether the images they are viewing have a pulse or not, nor the ratio of pulse to no-pulse in the images they review. The entire sample of ultrasound images will be block randomised, so that the order is different for each reader, but each scan is not reviewed more than once by an individual reader.

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

will be by R code : RandomSeq <- as.data.frame(block.random(n=x, c(video =y, iter =z)))

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

All data analysis will be performed using R statistical analysis software. Diagnostic test criteria will be generated an analysed using the epitests package. Youden’s index and the comparison of Youden’s index between different mean arterial pressure will be performed using either the cutpoint R or optimalcutpoints packages and also the DTCompare package. A significance level of 0.05 will be considered significant.

Missing data plan.

We plan to reduce the amount of potential missing data by collecting only information relevant to the study and its outcomes.

As this is a paired-patient study, ideally we will collect a video from all three MAP ranges (20-30mmHg, 40-50mmHg, 60-70 mmHg) from each patient. In the situation where we are not able to collect all three MAP ranges from each patient, we will use a complete case analysis approach and removing all of the patient in who three videos could not be obtained. It is anticipated that this will occur infrequently, so that in seeking a maximum of 30 patients we should obtain all four videos for our minimum sample size of 24.

If we cannot obtain a carotid US video of the three MAP ranges in more than six patients, we will then look at either widening the MAP ranges in subsequent videos or changing to an available-case approach and combining all available videos so that the final video data-set has an equal proportion of videos numbers per MAP range, but in an unpaired approach. This would not alter the method of analysis but would reduce the power of the study. Of this were to occur we would consult a statistician for advice on the number of readers than would be required to adequately power the study (something we could not do until after the carotid US videos are collected).

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

COVID-19 prevented us form reaching full sample size for carotid US patients

Date of first participant enrolment

Anticipated

30/09/2019

Actual

4/10/2019

Date of last participant enrolment

Anticipated

Actual

13/05/2020

Date of last data collection

Anticipated

Actual

13/05/2020

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, Kogarah

Address [1]

Gray St,
Kogarah
NSW 2217

Country [1]

Australia

Primary sponsor type

Hospital

Name

St George Hospital, Kogarah

Address

Gray St,
Kogarah
2217 NSW, 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 Human Research Ethics Committee

Ethics committee address [1]

Prince of Wales Hospital 
G71 East Wing , Edmund Blacket Building
Randwick 
NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2019

Approval date [1]

25/09/2019

Ethics approval number [1]

2019/ETH00568

Summary

Brief summary

Current cardiac arrest algorithms require assessment of the return of spontaneous circulation (ROSC) following rhythm checks by observation for patient movement or spontaneous respirations, both of which may be absent in sedated and paralysed patients. Healthcare professionals may also check for a  pulse in the presence of an organized rhythm, however manual pulse checks have been demonstrated to be unreliable, even when performed by health professionals.  

There have been two papers published from St George Hospital (Sydney) related to the use of ultrasound (US) of central pulses and whether they may be an alternative to manual pulse checks. The first was a case report where US of the femoral artery demonstrated ROSC and guided subsequent resuscitation, following cardiac arrest in a patient where manual pulses were absent. The second was an  investigation into the inter-rater reliability of carotid US in detecting the return of a pulse, using cardiac surgery patients coming off bypass (where they go from no-pulse to a pulse). This showed a high intraclass correlation (0.86) for two-dimension (2D) ultrasound when detecting the return of a pulse.

This current study seeks to extend on these previous efforts by assessing the validity of carotid US in detecting the presence/absence of a pulse. We hope to use cardiac surgery patients as a human model for the presence and absence of a pulse by obtaining 2D US of the carotid arteries when not on bypass (when there is a pulse), and on bypass (when a pulse is not present). We will then present these videos to critical care physicians who are familiar with US and would be likely to perform an US in a cardiac arrest. We will assess the validity using diagnostic test criteria for subgroups of MAP, and the cohort as a whole. Our gold standard will be presence or absence of a pulsatile waveform on the participants radial artery pressure monitoring.

Trial website

Trial related presentations / publications

Public notes

Germanoska, B., Coady, M., Ng, S., Fermanis, G., & Miller, M. (2018). The reliability of carotid ultrasound in determining the return of pulsatile flow: A pilot study. Ultrasound, 26(2), 118–126. http://doi.org/10.1177/1742271X17753467

Miller, M., Grant, P., Cases, M. K. A., 2015. Return of spontaneous circulation confirmed by two dimensional ultrasound following pulseless electrical activity arrest. Anaesthesia Cases. Wiley Online Library
. http://doi.org/10.21466/ac.ROSCCBT.2015

Contacts

Principal investigator

Name

Dr Matthew Miller

Address

Department of Anaesthesia
St George Hospital
Gray St,
Kogarah
NSW 2217

Country

Australia

Phone

+61 2 9113 1111

Fax

matthew.miller1@health.nsw.gov.au

Contact person for public queries

Name

Matthew Miller

Address

Department of Anaesthesia
St George Hospital
Gray St,
Kogarah
NSW 2217

Country

Australia

Phone

+61 2 9113 1111

Fax

matthew.miller1@health.nsw.gov.au

Contact person for scientific queries

Name

Matthew Miller

Address

Department of Anaesthesia
St George Hospital
Gray St,
Kogarah
NSW 2217

Country

Australia

Phone

+61 2 9113 1111

Fax

matthew.miller1@health.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

they will be mostly large video files which will be too big to share, however we will be asking permission to share the data from participants. If the ethics committee agree that we can share the data with the participants permission, we will do so

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	Assessing the validity of two-dimensional carotid ultrasound to detect the presence and absence of a pulse.	2020	https://dx.doi.org/10.1016/j.resuscitation.2020.10.002

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

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Documents added manually

Documents added automatically