ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12623000178640

Ethics application status

Approved

Date submitted

7/02/2023

Date registered

21/02/2023

Date last updated

21/02/2023

Date data sharing statement initially provided

21/02/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of ingesting carbohydrate drink on stomach size and cardiac flow in healthy volunteers

Scientific title

Effect of Enhanced Recovery After Surgery (ERAS) prescribed preoperative carbohydrate drinks on gastric state and cardiac output in healthy volunteers

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

cardiac output

gastric volume

Condition category

Condition code

Anaesthesiology

Anaesthetics

Cardiovascular

Normal development and function of the cardiovascular system

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Ingestion of carbohydrate pre-operative drink. Specifically, Nutricia PreOp carbohydrate drink. 400ml total volume per candidates. This will be delivered to participants in the presence of a ANZCA Fellow. Each participant will orally ingest this 400ml volume once over the course of 5 minutes. This will occur in a clinical setting i.e, the anaesthetic department of St Vincent's Hospital. Ingestion of this carbohydrate drink is routine for colorectal surgery patients at St Vincent's Hospital. Participants will be healthy volunteers - not surgical candidates. The drink will be provided to the participant shortly after checking into the trial site.
Participants will then be assessed intermittently for a period of 2 hours after ingestion.
This will include a baseline assessment using ultrasound, then the same assessment at 30 minutes, 60 minutes and 120 minutes after ingestion.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in cardiac output (CO) measured by transthoracic echocardiography, specifically the product of stroke volume (SV) and heart rate (HR). This will be a composite primary outcome, the change in the product of SV and HR will give the change in CO.
Stroke volume will be determined by non-invasive transthoracic echocardiography (TTE) specifically utilising the left ventricular outflow tract (LVOT) velocity time integral (VTI) and the LVOT diameter.

Timepoint [1]

Immediately after consumption, then 30, 60 and 120 minutes (primary timepoint) after ingestion of the carbohydrate drink.

Secondary outcome [1]

Change in gastric volume.
Gastric volume (GV) will be determined by non-invasive gastric ultrasound utilising the gastric antrum cross-sectional area (CSA) and candidate age via the following validated formula:
GV (ml) = 27.0 + (14.6 x CSA (cm2)) - 1.28 x age (yr)

Timepoint [1]

Immediately after consumption, then 30, 60 and 120 minutes after ingestion of the carbohydrate drink.

Eligibility

Key inclusion criteria

Candidates must be available to attend St Vincent’s Hospital Melbourne for the study to be completed and;
They must be willing to have an ultrasound probe pressed against specific areas of the body, specifically the abdomen and thorax (to be exact the front left chest) and;
They must be willing to fast for 6 hours then ingest carbohydrate-containing liquid drink

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Candidates who decline to have ultrasound investigations performed on their thorax or abdomen; or
Candidates who are trainees or employees of the anaesthetic department of St Vincent's Hospital Melbourne or
Candidates who knowingly have gastric disease or cardiovascular disease (as these conditions will impact the interpretation and usefulness of the results)

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Primary outcome: paired t-test.
Secondary outcomes: paired t-test; analysis of variants for multiple timepoints

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

27/02/2023

Actual

Date of last participant enrolment

Anticipated

26/06/2023

Actual

Date of last data collection

Anticipated

31/07/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Melbourne

Address [1]

41 Victoria Parade Fitzroy 3065 Victoria

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Harsh Dubey

Address

St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy 3065 Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)

Ethics committee address [1]

41 Victoria Parade Fitzroy 3065 Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/09/2022

Approval date [1]

13/01/2023

Ethics approval number [1]

ERM 87104; SAGE 2022/PID06427; HREC 181/22

Summary

Brief summary

ERAS (enhanced recovery after surgery) protocols have been demonstrated to improve certain surgical outcomes. St Vincent’s Hospital Melbourne employs an ERAS protocol for colorectal surgical candidates. Among many measures, is the provision for ingestion of 400ml of carbohydrate fluid 2 hours before surgery. This intervention aims to reduce patient length of stay at no increased risk of aspiration events. Contemporary literature includes several studies that aim to investigate the transit of preoperative carbohydrate ingestion via non-invasive gastric ultrasound, specifically utilising gastric antrum cross sectional area (CSA). These studies find that the transit of carbohydrate oral drinks, ingested at least 2 hours before surgery, do not remain in the stomach upon intubation: the pre-operative ingestion does not appear to increase the risk of pulmonary aspiration caused by an ‘at risk’ stomach.  

Any potential changes to a patient's haemodynamic state caused by ingestion of this fluid however, have not been investigated to date. Understanding the haemodynamic effect of this intervention would aid the clinician (i.e., the anaesthetist) in their attempt to provide patient-centred, safe, peri-operative fluid management. This is important, as failure to safely manage a patient's fluid status could precipitate deleterious states such as fluid overload (too much fluid) or hypovolemia (too little fluid).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Harsh Dubey

Address

St Vincent's Hospital Public, Melbourne
41 Victoria Parade Fitzroy Victoria 3065

Country

Australia

Phone

+61 448 913 718

Fax

harshdubey8@gmail.com

Contact person for public queries

Name

Harsh Dubey

Address

St Vincent's Hospital Public, Melbourne
41 Victoria Parade Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 9231 2211

Fax

harshdubey8@gmail.com

Contact person for scientific queries

Name

Brian Cowie

Address

St Vincent's Hospital Public, Melbourne
41 Victoria Parade Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 9231 2211

Fax

brian.cowie@svha.org.au

Data sharing statement

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

Yes

What data in particular will be shared?

Individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

Start: 31/07/2024
End: 31/07/2028

Available to whom?

Researchers at an academic centre with ethics approval

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Via direct email/correspondence to the principle investigator at harshdubey8@gmail.com

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18282	Ethical approval					385339-(Uploaded-07-02-2023-20-47-01)-Study-related document.pdf

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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