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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
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Scientific title
Gastric Residual Volume Assessment by Stomach Ultrasound Compared to Aspiration in the Intensive Care Unit patients
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Secondary ID [1]
312549
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical illness
334434
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Critical illness
334435
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Condition category
Condition code
Emergency medicine
331063
331063
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0
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Other emergency care
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Oral and Gastrointestinal
331153
331153
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
329065
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Not applicable
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Comparator / control treatment
The volume of aspirated gastric contents following the 2nd of two ultrasound procedures will be the comparator in this study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Stomach ultrasound bias
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Assessment method [1]
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Specificity of ultrasound gastric volume assessment when compared to aspirated fluid measured in milliliters.
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Timepoint [1]
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Post aspiration of stomach contents
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Secondary outcome [1]
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To assess feasibility of bedside gastric ultrasound
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Assessment method [1]
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Review of any reported technical or patient-related difficulties encountered during the performance of the gastric ultrasound as documented by the notes taken by the medical doctor that performs the ultrasound
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Timepoint [1]
437622
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As experienced during the performance of the gastric ultrasound and as assessments at the end of each gastric ultrasound.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
1/08/2024
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Date of last participant enrolment
Anticipated
31/10/2024
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26810
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
42861
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Austin Hospital
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Address [1]
316975
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Country [1]
316975
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319223
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Individual
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Name [1]
319223
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Professor Rinaldo Bellomo - Austin Hospital
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Address [1]
319223
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Country [1]
319223
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315730
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
315730
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
315730
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Australia
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Date submitted for ethics approval [1]
315730
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15/03/2024
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Approval date [1]
315730
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15/07/2024
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Ethics approval number [1]
315730
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HREC/10681/Austin-2024
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Summary
Brief summary
In critically ill patients, especially those requiring mechanical ventilation, enteral nutrition is a fundamental aspect of metabolic support. When oral feeding is insufficient to meet nutritional needs, enteral feeding becomes the preferred method of nutritional support. However, more than 50% of ICU patients experience gastric dysmotility, which leads to reduced rates of gastric emptying. This can result in several complications, such as regurgitation and aspiration, increasing the risk of developing pneumonia. Therefore, monitoring gastric emptying is an essential part of ICU management, aimed at reducing these risks and making informed decisions regarding nutritional support. We hypothesize that there will be a close relationship between ultrasound of the stomach and aspiration for the assessment of gastric residual volume in patients admitted to the intensive care unit. In a convenience sample of 30 adult patients admitted to the intensive care unit, we will Sequential assessment of gastric residual volume performed first by ultrasound of the stomach followed by aspiration of the stomach contents with the volume of the aspirated fluid measured. Two ultrasound procedures will be performed by two independent intensive care doctors. Aspiration of the stomach contents will be performed by the patient’s bedside critical care nurse immediately following completion of the 2nd ultrasound.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Rinaldo Bellomo
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Address
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
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Australia
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Phone
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+61 394964835
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Fax
135626
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Email
135626
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[email protected]
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Contact person for public queries
Name
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Rinaldo Bellomo
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Address
135627
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
135627
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Australia
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Phone
135627
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+61 394964835
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Fax
135627
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Email
135627
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[email protected]
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Contact person for scientific queries
Name
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Rinaldo Bellomo
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Address
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
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Australia
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Phone
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+61 394964835
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Fax
135628
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Email
135628
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Ethics approval not sought for sharing of patient data
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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.
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