ANZCTR - Registration

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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]

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

Obesity

Urgent, emergency surgery or trauma surgery

Diabetes

Renal Dysfunction

Condition category

Condition code

Anaesthesiology

Anaesthetics

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

197 Wellington Street
Perth
WA
6000

Country [1]

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]

Individual

Name [1]

Dr Tomas Corcoran

Address [1]

C/o Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth
WA
6000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital Ethics committee

Ethics committee address [1]

Ethics Office 
Level 5 Colonial House, 
Royal Perth Hospital, 
GPO Box X2213 Perth WA 6001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2012

Approval date [1]

23/10/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

James Walker

Address

C/O Anaesthetic Department
Royal Perth Hospital
Wellington Street
Perth
WA
6000

Country

Australia

Phone

+610892241038

Fax

[email protected]

Contact person for scientific queries

Name

Professor Corcoran

Address

C/O Anaesthetic Department
Royal Perth Hospital
Wellington Street
Perth
WA
6000

Country

Australia

Phone

+610892241038

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Preoperative Gastric Residual Volumes in Fasted Patients Measured by Bedside Ultrasound: A Prospective Observational Study.	2018	https://dx.doi.org/10.1177/0310057X1804600612

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically