Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001106628
Ethics application status
Approved
Date submitted
21/09/2014
Date registered
17/10/2014
Date last updated
30/06/2021
Date data sharing statement initially provided
30/06/2021
Date results information initially provided
30/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastric emptying after ingestion of clear fluids and nutritional liquid
Scientific title
Assessing the duration of gastric emptying by ultrasound after ingesting clear fluid and nutritional liquid in healthy volunteers.
Secondary ID [1] 285377 0
None
Universal Trial Number (UTN)
U1111-1162-0122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspiration pneumonia 293108 0
Condition category
Condition code
Oral and Gastrointestinal 293381 293381 0 0
Normal oral and gastrointestinal development and function
Respiratory 293417 293417 0 0
Other respiratory disorders / diseases
Infection 293418 293418 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty volunteers will fast at least for 6 hours for food and for 2 hours for clear liquid prior to this study. Gastric ultrasound is done to determine the baseline gastric residual volume (GRV). The volunteers are then randomised into two groups, one receiving 250mls of nutritional liquid (Up and Go, which contains protein 8.3g, total fat 3.8g, saturated fat 0.5g, carbohydorate 30.3g, sugars 19.0g, sodium 163mg, dietary fibre 3.8g, monounsaturated 1.5g, polyunsaturated 1.8g, potassium 538mg, folic acid 100mcg, viatminA 128mcg, Vitamin B1 0.28mg, Vitamin B2 0.28mg, Vitamin B3 2.5mg, Vitamin B6 0.40mg, Vitamin B12, Vitamin C 10.0mg, calcium 400mg, energy 198cal) and the other 250mls of clear fluid (water). Gastric ultrasound is done immediately post ingestion then every 10 minutes for the 1st 30 mins then every hour until the gastric volume returns to baseline.
After each volunteer's gastric volume has returned to baseline, he/she will then crossover to the other group and the process is repeated.
Intervention code [1] 290290 0
Prevention
Comparator / control treatment
Drinking water
Control group
Active

Outcomes
Primary outcome [1] 293209 0
Primary outcome 1: The duration required for gastric emptying after ingestion of fluid with the same caloric composition(Up&Go) as a standard meal and clear fluid(water) of equal volume, which will be assessed by gastric ultrasound.
Timepoint [1] 293209 0
Immediately post ingestion then every 10 minutes for the 1st 30 mins then every hour until the gastric volume returns to baseline.
Primary outcome [2] 293210 0
Primary outcome 2: Whether ingesting water prior to ingesting Up&Go influences the speed of gastric emptying or not which will be assessed by gastric ultrasound only when water is ingested first. The order of treatments is randomised.
Timepoint [2] 293210 0
Immediately post ingestion then every 10 minutes until the gastric volume returns to baseline.
Secondary outcome [1] 310599 0
Correlation of scanning technique between two operators. The technique will be assessed by the results of the calculated cross sectional area of stomachs.
Timepoint [1] 310599 0
When the study is completed.

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous gastro-oesophageal surgery or abnormality of the gastrointestinal tract
Recent Pregnancy (within 3 months)
Age less than 18
Unable to give informed consent themselves
Hiatus Hernia
History of gastroesophageal reflux
Cognitive impairement/ mental disability
Those unable to lie still

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a "Research Randomizer".
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Prospective
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2014
Actual
18/09/2014
Date of last participant enrolment
Anticipated
Actual
20/12/2014
Date of last data collection
Anticipated
Actual
20/12/2014
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3006 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 8718 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 289987 0
Hospital
Name [1] 289987 0
Department of Anaesthesia and Pain Medicine at Royal Perth Hospital
Country [1] 289987 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Medicine at Royal Perth Hospital
Address
197 Wellington Street, Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 288672 0
Hospital
Name [1] 288672 0
Department of Radiology and Imaging Service at Royal Perth Hospital
Address [1] 288672 0
197 Wellington Street, Perth, WA 6000
Country [1] 288672 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291695 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 291695 0
197 Wellington Street, Perth, WA 6000
Ethics committee country [1] 291695 0
Australia
Date submitted for ethics approval [1] 291695 0
09/12/2013
Approval date [1] 291695 0
31/07/2014
Ethics approval number [1] 291695 0
REG13-175

Summary
Brief summary
Aspiration pneumonia or pneumonitis is a fatal complication under general anaesthesia. Current fasting guidelines before general anaetshesia recommend 2 hours for clear fluid and 6 hours for light meal. However the guidelines do not account for the fact that some fasted surgical patients may still not have empty stomachs at that time of their surgery. The technique of gastric ultrasound to determine the types of gastric contents and the volume has been well described and standardised.

The hypothesis of this study is gastric volume will return to baseline more rapidly after ingestion of clear fluid as compared to a fluid equivalent of a standard meal.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 51586 0
Dr Yayoi Ohashi
Address 51586 0
Royal Perth Hospital
Department of anaesthesia and pain medicine
197 Wellington Street, Perth, WA 6000
Country 51586 0
Australia
Phone 51586 0
+61892241036
Fax 51586 0
Email 51586 0
Yayoi.Ohashi@health.wa.gov.au
Contact person for public queries
Name 51587 0
Prof Yayoi Ohashi
Address 51587 0
Royal Perth Hospital
197 Wellington Street, Perth, WA 6000
Country 51587 0
Australia
Phone 51587 0
+61892241036
Fax 51587 0
Email 51587 0
Yayoi.Ohashi@health.wa.gov.au
Contact person for scientific queries
Name 51588 0
Prof Tomas Corcoran
Address 51588 0
Royal Perth Hospital
Department of anaesthesia and pain medicine
197 Wellington Street, Perth, WA 6000
Country 51588 0
Australia
Phone 51588 0
+61892241036
Fax 51588 0
Email 51588 0
Tomas.Corcoran@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.