Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001185358
Ethics application status
Approved
Date submitted
7/08/2017
Date registered
11/08/2017
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Date results information initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Chewing Gum on Postoperative Nausea and Vomiting.
Scientific title
A Pilot Randomized Controlled Study on The Effects of Chewing Gum on Postoperative Nausea and Vomiting in Critically Ill Patients
Secondary ID [1] 292611 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The ECG PONV Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and Vomiting 304291 0
Condition category
Condition code
Oral and Gastrointestinal 303638 303638 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chewing mint flavoured gum four-hourly for up to 15 minutes during first 24 postoperative hours. Data will be collected if the intervention was given or not and the reason why it wasn't given if not.
Intervention code [1] 298823 0
Treatment: Other
Comparator / control treatment
Sipping 20 ml of water four-hourly for up to 15 minutes during first 24 postoperative hours.
Control group
Active

Outcomes
Primary outcome [1] 302998 0
Number of patient reported nausea episodes.
.
Timepoint [1] 302998 0
Reported in the first 24 postoperative hours as documented on the project's data collection form.
Primary outcome [2] 303002 0
Composite outcome of number of vomiting and dry retching episodes.
Timepoint [2] 303002 0
Reported in the first 24 postoperative hours as documented on the project's data collection form.
Primary outcome [3] 303003 0
Duration of nausea episodes.
Timepoint [3] 303003 0
Reported in the first 24 postoperative hours as documented on the project's data collection form.
Secondary outcome [1] 337652 0
Anti-emetic medication use.
Timepoint [1] 337652 0
Reported in the first 24 postoperative hours as documented in the patient's medical record.
Secondary outcome [2] 337728 0
Severity of nausea as assessed using a visual analogue scale from 0-10 every 4 hours.
Timepoint [2] 337728 0
Reported in the first 24 postoperative hours as documented on the project's data collection form.

Eligibility
Key inclusion criteria
Admission to Austin Hospital ICU
Age 18 year of greater
Immediate (Within 12 hours) post-operative period
An anticipated ICU length of stay of > 12 hours after randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ongoing mechanical ventilation with endotracheal tube.
Inability to chew due to presence of dentures
Inability to chew due to oropharngeal or maxillary surgery
Admission after oesophageal surgery
Recent Extubation < 1 hours
Dysphagia

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a recent pilot study, the use of Chewing Gum decreased the incidence of PONV from 75% to 39%. However we believe we should take a conservative view and hypothesize a smaller decrease from 75% to 50%. We Estimate 90 patients will be needed to have 80% power at an alpha of 0.05 for significance.

Variables will be assessed for normality and log transformed if appropriate. Baseline comparisons will be performed using Fischer's exact tests and reported as n(%). Continuous normally distributed variables will be compared using Student t-tests and reported as medians [interquartile range]. Comparison of ordinal outcomes will be by means of Fisher's exact test. A P<0.05 will be considered significant.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/08/2017
Actual
18/10/2017
Date of last participant enrolment
Anticipated
Actual
31/01/2019
Date of last data collection
Anticipated
Actual
31/01/2020
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8697 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 16809 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 297198 0
Hospital
Name [1] 297198 0
Austin Hospital, Anaesthesia Intensive Care Trust Fund
Country [1] 297198 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Hospital
145 Studely Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 296206 0
Individual
Name [1] 296206 0
Prof Rinaldo Bellomo
Address [1] 296206 0
Department of Intensive Care
Austin Hospital
145 Studely Road
Heidelberg VIC 3084
Country [1] 296206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298354 0
Austin Health Human Research Ethich Comittee
Ethics committee address [1] 298354 0
145 Studely Road
Heidelberg VIC 3084
Ethics committee country [1] 298354 0
Australia
Date submitted for ethics approval [1] 298354 0
28/04/2017
Approval date [1] 298354 0
29/06/2017
Ethics approval number [1] 298354 0
LNR/17/Austin/205

Summary
Brief summary
Postoperative nausea and vomiting (PONV) is a common complication that may cause significant morbidity. It is usually treated with anti-emetics. Recently, Chewing Gum (GC) showed similar level of efficacy to ondansetron in a pilot controlled trial of surgical patients. Moreover, CG has bee shown to reduce postoperative gut malfunction and vomiting after colorectal surgery However, to date, CG has not bee studied in the prevention of PONV in patients admitted to the intensive care unit (ICU). Thus we aim to perform a study to evaluate the comparative effect of CG compared with the effects of taking a 20 ml sip of water in the prevention of PONV in patients admitted to the ICU after major surgery.
Patients will be randomly allocated to be given sugarless plain CG or a 20 ml sip of water 4 hourly for 24 hours. The nurse looking after the patient will record the effects of the intervention on the presence of nausea, its duration, and severity using a visual analogue scale every 4 hours. The number of episodes of vomiting and retching will be recorded. Rescue anti-emetic therapy if the nausea is rated > 5, or if vomiting has occurred. Nausea and vomiting assessments will be made 30 minutes after the patient had been given rescue medication.
If the CG intervention proves effective, it will represent an important and easily deployed, safe step towards making the patient's post-operative period less distressing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76818 0
Prof Rinaldo Bellomo
Address 76818 0
Department of Intensive Care
Austin Hospital
145 Studely Road
Heidelberg VIC 3084
Country 76818 0
Australia
Phone 76818 0
+61 3 9496 5992
Fax 76818 0
+61 3 9496 3932
Email 76818 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 76819 0
Glenn Eastwood
Address 76819 0
Department of Intensive Care
Austin Hospital
145 Studely Road
Heidelberg VIC 3084
Country 76819 0
Australia
Phone 76819 0
+61 3 9496 4835
Fax 76819 0
+61 3 9496 3932
Email 76819 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 76820 0
Rinaldo Bellomo
Address 76820 0
Department of Intensive Care
Austin Hospital
145 Studely Road
Heidelberg VIC 3084
Country 76820 0
Australia
Phone 76820 0
+61 3 9496 5992
Fax 76820 0
+61 3 9496 3932
Email 76820 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.