Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001216808
Ethics application status
Approved
Date submitted
15/11/2012
Date registered
16/11/2012
Date last updated
16/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comorbidities and Pre-operative Gastric Ultrasound Assessment
Scientific title
Preoperative fasted surgical patients undergoing gastric ultrasound assessment to determine gastric fluid volume - do comorbitities influence these gastric volumes?
Secondary ID [1] 281506 0
Nil
Universal Trial Number (UTN)
U1111-1136-7624
Trial acronym
CAPGU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastric reflux 287833 0
Obesity 287834 0
Urgent, emergency surgery or trauma surgery 287835 0
Diabetes 287836 0
Renal Dysfunction 287837 0
Condition category
Condition code
Anaesthesiology 288124 288124 0 0
Anaesthetics
Oral and Gastrointestinal 288180 288180 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ultrasound scan of gastric antrum . This involves placing ultrasound jelly on the epigastric area of the patient then placing a curvilinear ultrasound plastic probe on the epigastric area of the abdomen to produce a picture of the gastric antrum - this is done with the patient in the lateral decubitus position (on their side). The scan will take a duration of circa 2 minutes which can approximate total gastric fluid volume using a validated formula
Intervention code [1] 286021 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288375 0
Ability to determine gastric volume in 243 patients using gastric antrum ultrasound (uses a previously validated formula which converts gastric antrum cross sectional area on ultrasound to total a total gastric volume
Timepoint [1] 288375 0
Each consented, fasted patient has the gastric antrum measured by ultrasound pre-operatively - duration circa 2 minutes only. The gastric antrum image is taken. The still image is then analysed by calipers and circumferential tracing which delivers a cm2 antral volume in the same instance (part of the two minutes). This figures is then fed into a formula on a database on a computer at the same time which delivers the final gastric fluid volume.
Secondary outcome [1] 299999 0
Comorbidities - we will analyse the data from the primary outcome to determine whether or not comorbidities efffect gastric volumes in the fasted patient using the above technique. The source of this data is by medical records and by direct patient questioning.
Timepoint [1] 299999 0
Post data collection analysis of groups

Eligibility
Key inclusion criteria
ASA (american society of anaesthesiologists) grade 1-3
Starvation times more than 2 hours for clear fluids and 6 hours for food

Please see exclusion criteria... gastrointestinal abnormalities are excluded and also those who have had gastrointestinal surgery previously as this distorts the gastric antrum. All surgical specialities will be included aside from cardiothoracic patients.
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
Patients who have not been starved for food fo 6 hours and clear fluids for more than 2 hours
Cognitive impairement/ mental disability
Those unable to lie still for ultrasound assessment
Cardiothoracic surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
243
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286337 0
Hospital
Name [1] 286337 0
Royal Perth Hospital
Country [1] 286337 0
Australia
Primary sponsor type
Individual
Name
Dr James Walker
Address
C/o Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth
WA
6000
Country
Australia
Secondary sponsor category [1] 285129 0
Individual
Name [1] 285129 0
Dr Tomas Corcoran
Address [1] 285129 0
C/o Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth
WA
6000
Country [1] 285129 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288413 0
Royal Perth Hospital Ethics committee
Ethics committee address [1] 288413 0
Ethics Office
Level 5 Colonial House,
Royal Perth Hospital,
GPO Box X2213 Perth WA 6001
Ethics committee country [1] 288413 0
Australia
Date submitted for ethics approval [1] 288413 0
01/10/2012
Approval date [1] 288413 0
23/10/2012
Ethics approval number [1] 288413 0
EC 2012/162

Summary
Brief summary
The inhalation of gastric (stomach) contents in to the lungs (pulmonary aspiration) has significant morbidity and mortality and can attribute to up to 9% of anaesthetic related deaths. [1] [2] In a large retrospective analysis, pulmonary aspiration occurs between 1:900 emergency patients and one in 3900 elective patients [3] A key risk factor for pulmonary aspiration is the volume of the aspirated gastric content.

In certain subgroups of patients such as those with trauma, pulmonary aspiration can be as high has 34%. [4] Preoperative fasting guidelines aim to reduce the risk of pulmonary aspiration for the majority of patients undergoing anaesthesia. This is normally 6 hours for solid food and 2 hours for clear fluids in our institution (Royal Perth Hospital). Despite these guidelines there remain high risk groups in whom significant residual gastric volumes can remain despite adequate fasting - this is because they take longer to clear their gastric contents. These include patients with diabetes, liver or kidney dysfunction or pregnancy and trauma patients. [5]
Previous methods for determining gastric content preoperatively have been invasive and lengthy procedures. Non-invasive gastric ultrasound however can now reliably estimate gastric volume and content. [5] [6] Ultrasound represents a convenient bedside portable tool that can be used to help guide anaesthetists managing the anaesthetic risk for these high risk groups.

This prospective cohort study aims to quantify the risk of aspiration by gastric volumes for those with renal dysfunction, emergency or urgent surgery, diabetes, gastro-oesophageal reflux disease (GORD) and obesity as indicated by preoperative gastric ultrasound using a standardised technique [1, 5]
1. Perlas, A., et al., Ultrasound assessment of gastric content and volume. Anesthesiology. 111(1): p. 82-9.
2. Landreau, B., I. Odin, and N. Nathan, [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim, 2009. 28(3): p. 206-10.
3. Warner, M.A., M.E. Warner, and J.G. Weber, Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993. 78(1): p. 56-62.
4. Lockey, D.J., T. Coats, and M.J. Parr, Aspiration in severe trauma: a prospective study. Anaesthesia. 54(11): p. 1097-8.
5. Perlas, A., et al., Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg, 2011. 113(1): p. 93-7.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34927 0
Address 34927 0
Country 34927 0
Phone 34927 0
Fax 34927 0
Email 34927 0
Contact person for public queries
Name 18174 0
James Walker
Address 18174 0
C/O Anaesthetic Department
Royal Perth Hospital
Wellington Street
Perth
WA
6000
Country 18174 0
Australia
Phone 18174 0
+610892241038
Fax 18174 0
Email 18174 0
[email protected]
Contact person for scientific queries
Name 9102 0
Professor Corcoran
Address 9102 0
C/O Anaesthetic Department
Royal Perth Hospital
Wellington Street
Perth
WA
6000
Country 9102 0
Australia
Phone 9102 0
+610892241038
Fax 9102 0
Email 9102 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbasePreoperative Gastric Residual Volumes in Fasted Patients Measured by Bedside Ultrasound: A Prospective Observational Study.2018https://dx.doi.org/10.1177/0310057X1804600612
N.B. These documents automatically identified may not have been verified by the study sponsor.