Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000928516
Ethics application status
Approved
Date submitted
17/07/2024
Date registered
1/08/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Gastric Residual Volume Assessment by Stomach Ultrasound Compared to Aspiration in the Intensive Care Unit
Scientific title
Gastric Residual Volume Assessment by Stomach Ultrasound Compared to Aspiration in the Intensive Care Unit patients
Secondary ID [1] 312549 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 334434 0
Critical illness 334435 0
Condition category
Condition code
Emergency medicine 331063 331063 0 0
Other emergency care
Oral and Gastrointestinal 331153 331153 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In patients where aspiration of gastric contents will occur regardless of their involvement in this study, sequential assessment of gastric residual volume performed first by repeated ultrasound examinations of the stomach followed by aspiration of the stomach contents with the volume of the aspirated fluid then measured will be performed. The two ultrasound procedures will be performed by two independent intensive care doctors, with each intensive care doctor performing one ultrasound procedure each. Each ultrasound procedure is anticipated to take 15 minutes. Aspiration of the stomach contents will be performed by the patient’s bedside critical care nurse immediately following completion of the 2nd ultrasound. The total duration of the two ultrasound assessments and then the aspiration of stomach contents is anticipated to be 45-50 minutes. Participant's will be those already in the ICU and deemed necessary to have aspiration of stomach contents within routine care.
Intervention code [1] 329065 0
Not applicable
Comparator / control treatment
The volume of aspirated gastric contents following the 2nd of two ultrasound procedures will be the comparator in this study.
Control group
Active

Outcomes
Primary outcome [1] 338832 0
Stomach ultrasound bias
Timepoint [1] 338832 0
Post aspiration of stomach contents
Secondary outcome [1] 437622 0
To assess feasibility of bedside gastric ultrasound
Timepoint [1] 437622 0
As experienced during the performance of the gastric ultrasound and as assessments at the end of each gastric ultrasound.

Eligibility
Key inclusion criteria
Aged equal to or greater than 18 years
Have a nasogastric tube or orogastric tube in place as a part of routine care
Admitted to intensive care unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Neuromuscular disease
Admitted to the intensive care unit following gastric surgery
Known past medical history that includes gastric surgery or known gastric motility disorders
Presence of upper gastrointestinal tract abnormalities, gastric tumours of hiatal hernia
Suspected or confirmed pregnancy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Baseline characteristics will be expressed as numbers and percentages, means and standard deviations, or medians and interquartile ranges, as appropriate. Paired ultrasound and aspiration volume measurement will be examined using Bland-Altman to calculate bias (difference in means, d), standard deviation (SD) of the differences (precision, s) and limits of agreement (plus or minus 2 SD). The statistical significance of the bias will be estimated with a paired Student’s t-test. Secondary outcomes will be examined by a combination of non-parametric and parametric statistical tests which may include multivariable linear and logistic regression analyses, as appropriate. Within our analyses, we will collect data to compare nutritional intake and complications associated with ultrasound procedure performance from the electronic medical record.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
1/08/2024
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26810 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 42861 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 316975 0
Hospital
Name [1] 316975 0
Austin Hospital
Country [1] 316975 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 319223 0
Individual
Name [1] 319223 0
Professor Rinaldo Bellomo - Austin Hospital
Address [1] 319223 0
Country [1] 319223 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315730 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 315730 0
Ethics committee country [1] 315730 0
Australia
Date submitted for ethics approval [1] 315730 0
15/03/2024
Approval date [1] 315730 0
15/07/2024
Ethics approval number [1] 315730 0
HREC/10681/Austin-2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135626 0
Prof Rinaldo Bellomo
Address 135626 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 135626 0
Australia
Phone 135626 0
+61 394964835
Fax 135626 0
Email 135626 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 135627 0
Rinaldo Bellomo
Address 135627 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 135627 0
Australia
Phone 135627 0
+61 394964835
Fax 135627 0
Email 135627 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 135628 0
Rinaldo Bellomo
Address 135628 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 135628 0
Australia
Phone 135628 0
+61 394964835
Fax 135628 0
Email 135628 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval not sought for sharing of patient data


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.