Trial Review

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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] 308913 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac output
 328914 0
gastric volume 328915 0
Condition category
Condition code
Anaesthesiology 325906 325906 0 0
Anaesthetics
Cardiovascular 325907 325907 0 0
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] 325357 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333737 0
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] 333737 0
Immediately after consumption, then 30, 60 and 120 minutes (primary timepoint) after ingestion of the carbohydrate drink.
Secondary outcome [1] 418304 0
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] 418304 0
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
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23957 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 39446 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 313123 0
Hospital
Name [1] 313123 0
St Vincent's Hospital Melbourne
Country [1] 313123 0
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] 314824 0
None
Name [1] 314824 0
Address [1] 314824 0
Country [1] 314824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312370 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 312370 0
41 Victoria Parade Fitzroy 3065 Victoria
Ethics committee country [1] 312370 0
Australia
Date submitted for ethics approval [1] 312370 0
09/09/2022
Approval date [1] 312370 0
13/01/2023
Ethics approval number [1] 312370 0
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 124414 0
Dr Harsh Dubey
Address 124414 0
St Vincent's Hospital Public, Melbourne
41 Victoria Parade Fitzroy Victoria 3065
Country 124414 0
Australia
Phone 124414 0
+61 448 913 718
Fax 124414 0
Email 124414 0
harshdubey8@gmail.com
Contact person for public queries
Name 124415 0
Dr Harsh Dubey
Address 124415 0
St Vincent's Hospital Public, Melbourne
41 Victoria Parade Fitzroy Victoria 3065
Country 124415 0
Australia
Phone 124415 0
+61 3 9231 2211
Fax 124415 0
Email 124415 0
harshdubey8@gmail.com
Contact person for scientific queries
Name 124416 0
A/Prof Brian Cowie
Address 124416 0
St Vincent's Hospital Public, Melbourne
41 Victoria Parade Fitzroy Victoria 3065
Country 124416 0
Australia
Phone 124416 0
+61 3 9231 2211
Fax 124416 0
Email 124416 0
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.TypeCitationLinkEmailOther DetailsAttachment
18282Ethical approval    385339-(Uploaded-07-02-2023-20-47-01)-Study-related document.pdf



Results publications and other study-related documents

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