ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619001232123

Ethics application status

Approved

Date submitted

5/08/2019

Date registered

6/09/2019

Date last updated

6/09/2019

Date data sharing statement initially provided

6/09/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of a short message service to improve compliance with fasting in patients undergoing elective surgery

Scientific title

Effects of a short message service (SMS) by cellular phone to improve compliance with fasting guidelines in patients undergoing elective surgery

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1238-0453

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pre-operative Fasting

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

- Participants in the intervention group received an additional prompt one day prior to surgery via a short-message service (SMS) containing a reminder of fasting times, in addition to receiving fasting guidelines as per the standard hospital policy.
- The SMS was sent once only, the day prior to surgery.
- A dedicated perioperative staff member confirmed the theatre list for the following day and then the SMS was sent times to the patient’s registered mobile phone with fasting times. SMS messages were sent by staff of the pre-operative day stay unit who were aware of the study protocol.
- The SMS was in the English language, clearly articulating the fasting times for both solids and liquids.
- Morning list patients were advised to “fast from midnight for solids” and “from 06:30 for liquids”. The afternoon list patients were advised to “fast from 07:30 for solids” and “from 11:30 for liquids”. Solids were described as a “very light meal e.g. cereal or toast”. Clear fluids were described “water, clear cordial or apple juice, or black tea or black coffee with NO milk”.

Intervention code [1]

Other interventions

Comparator / control treatment

The comparator/control was based on an audit of fasting times amongst elective surgery patients at Ballarat Health Service who received fasting guidelines as per the standard hospital policy.

Control group

Active

Outcomes

Primary outcome [1]

Length of fasting time for solids and fluids This outcome is assessed based on a patient questionnaire pre-operatively which was then recorded into medical records

Timepoint [1]

Peri-operative period (day before and day of surgery)

Secondary outcome [1]

Proportion of patients who fasted in accordance with recommended guidelines This outcome is assessed based on a patient questionnaire pre-operatively which was then recorded into medical records

Timepoint [1]

Peri-operative period (day before and day of surgery)

Eligibility

Key inclusion criteria

we included adult patients (>18 years) undergoing elective surgery with a day of surgery admission.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

We excluded patients undergoing emergency procedures, morbid obesity (body mass index > 35kg/m2), patients with previous gastric or bypass surgery, history of delayed gastric emptying, pregnant patients, and all inpatients.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/06/2016

Date of last participant enrolment

Anticipated

Actual

21/06/2016

Date of last data collection

Anticipated

Actual

21/06/2016

Sample size

Target

250

Accrual to date

Final

270

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment postcode(s) [1]

3350 - Ballarat Central

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Ballarat Health Service

Address [1]

Drummond St North Ballarat VIC 3350

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Laurence Weinberg

Address

Austin Health, Department of Anaesthesia, 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ballarat Health Services and St John of God Hospital Ballarat Human Research Ethics Committee

Ethics committee address [1]

Ballarat Health Services
Drummond Street North
Ballarat VIC 3350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/01/2016

Ethics approval number [1]

HREC/12/BHSSJOG/76

Summary

Brief summary

We performed an audit to determine the extent of prolonged and excessive fasting amongst elective surgery patients. We aimed to compare the actual fasting times of elective surgery patients to the recommended fasting times as per our institution’s guidelines. Additionally, we completed a quality improvement project aiming to determine whether notification of fasting times by short message service (SMS) the day before surgery would improve fasting times and reduce excessive fasting. 

We hypothesised that the usage of an SMS reminder one day prior to surgery would assist patients in adhering to fasting guidelines and thus reduce excessive fasting.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Laurence Weinberg

Address

Department of Anaesthesia Austin Health 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 3800

Fax

[email protected]

Contact person for public queries

Name

Laurence Weinberg

Address

Department of Anaesthesia Austin Health 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 3800

Fax

[email protected]

Contact person for scientific queries

Name

Laurence Weinberg

Address

Department of Anaesthesia Austin Health 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 3800

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• Complete database of all de-identified participant data

What types of analyses could be done with individual participant data?

• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
after publication with no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• by email contact of the principal investigator - [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3766	Ethical approval			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically