Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001377123p
Ethics application status
Submitted, not yet approved
Date submitted
12/06/2019
Date registered
9/10/2019
Date last updated
9/10/2019
Date data sharing statement initially provided
9/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasonographic evaluation of gastric contents in term pregnant women two hours post consumption of carbohydrate drink who present for elective caesarean section.
Scientific title
Ultrasonographic evaluation of gastric contents in term pregnant women two hours post consumption of carbohydrate drink who present for elective caesarean section.
Secondary ID [1] 298478 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 313252 0
Requiring elective Caesarean section 313253 0
Condition category
Condition code
Reproductive Health and Childbirth 311694 311694 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In our institution patients fasting for an elective Caesarean section routinely receive a perop carbohydrate drink-as is common in many institutions. We propose to measure the gastric contents of patients who have received a carbohydrate drink by conducting a brief (typically <3mins) bedside conducted by a registered radiographer ultrasound study of their stomach. This will occur 2 hours post consumption of the carbohydrate drink This is painless, free of harm and brief.
Intervention code [1] 314729 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320394 0
Gastric stomach volume will be either less than or greater than 1.5mls/kg at 2 hours post carbohydrate drink consumption as assessed by bedside ultrasound of gastric volume
Timepoint [1] 320394 0
2 hours post drink consumption
Secondary outcome [1] 371462 0
Estimation of total gastric volume at 2 hours post consumption of preop drink as assessed by bedside ultrasound.
Timepoint [1] 371462 0
2 hours post consumption of carbohydrate drink

Eligibility
Key inclusion criteria
Capacity to consent and informed consent given.
Females undergoing elective Caesarean section at Redlands Hospital
First Patient on elective Caesarean Section List.
Will have consumed 400mls of preop carbohydrate drink at 6am.
Will undergo ultrasonographic scanning at a time from 8.00 and 8.30 am.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to consent
Prior oesophageal of gastric surgery
Has vomited or failed to consume the prescribed preop drink.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Given the absence of useful data a power calculation was not possible. Having consulted with a Biostatistics service (Nicholas Martigan, PAH, Brisbane) we will recruit 10 patients and analyse the data from these 10 patients. We expect that we will demonstrate full gastric clearance in 100% of the recruited patients within this cohort. This sample size was also the sample size used in the study used to validate the ultrasonographic methodology that will be used to measure gastric volumes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
Date of last participant enrolment
Anticipated
1/12/2019
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13976 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 26753 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 303023 0
Hospital
Name [1] 303023 0
Redland Hospital
Country [1] 303023 0
Australia
Primary sponsor type
Hospital
Name
Redland hospital
Address
Dept Anaesthesia, Redland Hospital, Weppin St.,Cleveland, Qld 4163
Country
Australia
Secondary sponsor category [1] 303001 0
None
Name [1] 303001 0
Address [1] 303001 0
Country [1] 303001 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303572 0
Metro South HREC
Ethics committee address [1] 303572 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 303572 0
Australia
Date submitted for ethics approval [1] 303572 0
13/06/2019
Approval date [1] 303572 0
Ethics approval number [1] 303572 0

Summary
Brief summary
The study aims to demonstrate that 400 mls of a preop carbohydrate drink is fully cleared from the stomach 2hours after consumption in pregnant patients fasting for a caesarean section. All elective patients are subject to standard fasting guidelines-6h for food and 2h for clear liquid. In an effort to minimise physiological disruption to patients a carbohydrate drink (as opposed to water) has been given to patients fasting for operations. There is minimal data to in the heavily pregnant patient to demonstrate that a carbohydrate drink is cleared from the stomach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94126 0
Dr John Riordan
Address 94126 0
Dept. Anaesthesia
Redland Hospital
Weppin St.
Cleveland
Qld 4163
Country 94126 0
Australia
Phone 94126 0
+61 734883111
Fax 94126 0
Email 94126 0
[email protected]
Contact person for public queries
Name 94127 0
John Riordan
Address 94127 0
Dept. Anaesthesia,
Redland Hospital,
Weppin St.,
Cleveland,
Qld 4163
Country 94127 0
Australia
Phone 94127 0
+61 734883111
Fax 94127 0
Email 94127 0
[email protected]
Contact person for scientific queries
Name 94128 0
John Riordan
Address 94128 0
Dept. Anaesthesia
Redland Hospital
Weppin St.
Cleveland
Qld 4163
Country 94128 0
Australia
Phone 94128 0
+61 734883111
Fax 94128 0
Email 94128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified Data may be made available upon request to HREC/Editors/others as needed.
When will data be available (start and end dates)?
Start-End of recruitment, expected date July 2020
End-5 years post publication-expected date July 2026
Available to whom?
HREC/editors and researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Simple analysis of data
How or where can data be obtained?
Contacting lead author by email or post
Dr. John Riordan
Consultant Anaesthetist
Redland Hospital
Weppin St.
Cleveland
Qld 4163
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 377767-(Uploaded-12-02-2021-10-45-23)-Basic results summary.xlsx
Plain language summaryNo All patients had gastric ultrasound results consis... [More Details]

Documents added automatically
No additional documents have been identified.