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
ACTRN12619000132145
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
30/01/2019
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multicentre Randomized Controlled Trial of two interventions to manage dry mouth in pre-operative elective surgical patients.
Scientific title
A Multicentre Randomized Controlled Trial of two interventions to manage dry mouth in pre-operative elective surgical patients.
Secondary ID [1] 296993 0
None
Universal Trial Number (UTN)
Trial acronym
I AM DRY
Linked study record
This record is a follow-up of the pilot study registered under ACTRN12618001270202

Health condition
Health condition(s) or problem(s) studied:
Dry Mouth 310958 0
Condition category
Condition code
Anaesthesiology 309622 309622 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Saliva Substitute - Biotene Dry Mouth Oral Rinse
Preoperative patients who have offered their informed consent will be given 15 mls of Biotene to rinse their mouth. The patient is allowed to rinse their mouth for as long as they like and then spit out the liquid.
Patients will be asked to complete a Dry Mouth Score pre-intervention and 30 minutes post-treatment. The treatment can be repeated hourly until participants are transferred to the operating rooms from the preoperative area (there is no maximum time as patient stays in the preoperative are varied).
Intervention code [1] 313261 0
Prevention
Intervention code [2] 313262 0
Treatment: Other
Comparator / control treatment
Water
Preoperative patients who have offered their informed consent will be given 15 mls of water to rinse their mouth.
Patients will be asked to complete a Dry Mouth Score per-intervention and 30 minutes post-treatment.
The treatment can be repeated after 1 hour and subsequently hourly until participants leaves the preoperative area for the operating room.
Control group
Active

Outcomes
Primary outcome [1] 318580 0
Absolute risk reduction in mouth dryness represented by rating of mouth dryness on a 5 point Likert scale post intervention (much worse, worse, no change, better or much better).
Timepoint [1] 318580 0
30 minutes post intervention in pre-operative area
Secondary outcome [1] 365432 0
Difference in mouth dryness before and after intervention using a 100mm Visual Analogue Scale (VAS)
Timepoint [1] 365432 0
30 minutes after intervention
Secondary outcome [2] 365534 0
Incidence of harm related to intervention will be reported as an adverse event; such as allergic reaction symptoms to treatment - swollen mouth. Events will be recorded directly from participant self-reported and documentation in to medical records.

All adverse events will be reviewed and adjudicated by an independent review panel.
Timepoint [2] 365534 0
30 minutes post intervention

Eligibility
Key inclusion criteria
All patients undergoing elective surgery who meet all of the following criteria:
Elective adult surgical patients aged 18 years of age and older who:
Are able to consent to participate AND,
Have complied with local hospital fasting guidelines.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who did not comply with fasting guidelines.
Patients undergoing acute surgery.
Patients who do not give or cannot give consent to participate.

Study design
Purpose of the study
Treatment
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)
Block randomisation in groups of 8 utilising computer software generated tables,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Scientific outcomes will be described with simple inferential statistics.All analysis will be carried out with intention to treat rather than per protocol. Primary outcome data will be analysed using Chi-squared tests. A p value <0.05 will be taken as significant. Secondary outcome data will be analysed using a t-test with p values and confidence intervals. A p-value <0.05 will be taken as statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21169 0
New Zealand
State/province [1] 21169 0
Auckland
Country [2] 21170 0
New Zealand
State/province [2] 21170 0
Wellington
Country [3] 21171 0
New Zealand
State/province [3] 21171 0
Canterbury

Funding & Sponsors
Funding source category [1] 301564 0
Other Collaborative groups
Name [1] 301564 0
SATURN Trainee Network
Address [1] 301564 0
c/- Anaesthesia and Perioperative Research
Perioperative Services
Dept Anaesthesia Offices
Level 8
Building 1, Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country [1] 301564 0
New Zealand
Funding source category [2] 301597 0
Hospital
Name [2] 301597 0
Anaesthesia and Perioperative Research
Address [2] 301597 0
Perioperative Services
Dept Anaesthesia Offices
Level 8
Building 1, Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country [2] 301597 0
New Zealand
Primary sponsor type
Individual
Name
Dr Doug Campbell
Address
Perioperative Services
Dept Anaesthesia Offices
Level 8
Building 1, Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 301264 0
Other Collaborative groups
Name [1] 301264 0
SATURN Trainee Network
Address [1] 301264 0
c/- Anaesthesia and Perioperative Research
Perioperative Services
Dept Anaesthesia Offices
Level 8
Building 1, Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country [1] 301264 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302295 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 302295 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 302295 0
New Zealand
Date submitted for ethics approval [1] 302295 0
12/11/2018
Approval date [1] 302295 0
14/12/2018
Ethics approval number [1] 302295 0
18/CEN/237

Summary
Brief summary
Dry mouth, associated with fasting, stress, anxiety and pharmacological agents has been identified to be the most common perioperative patient complaint. In the pre-operative setting, dry mouth and thirst can be difficult to separate. Patient reported outcome measures such as pain, anxiety and nausea have multiple therapeutic options. Dry mouth is an important, but often overlooked patient reported outcome measure, with few therapeutic options. Dry mouth, is amenable to therapies including saliva substitutes, saliva stimulants and intravenous sialogues in oncological patients following surgery or radiotherapy and in autoimmune conditions. To date, the efficacy of these treatments has not been tested in the perioperative setting. Following a recent pilot study, BIG DRY aims to reduce the feeling of dry mouth in perioperative patients by comparing two simple treats, mouth wash and water.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89734 0
Dr Leesa Morton
Address 89734 0
Dept Anaethesia
Christchurch Hospital
Private Bag 4710
Christchurch
Country 89734 0
New Zealand
Phone 89734 0
+64 33640288
Fax 89734 0
Email 89734 0
leesa.morton@cdhb.health.nz
Contact person for public queries
Name 89735 0
Ms Davina McAllister
Address 89735 0
Anaethesia and Perioperative Research
Dept Anaesthesia
Perioperative Services
Level 8, Building 1
Auckland City Hospital
Park Road
Grafton
Auckland
Country 89735 0
New Zealand
Phone 89735 0
+64 93757095
Fax 89735 0
+6493754378
Email 89735 0
anaesresearch@adhb.govt.nz
Contact person for scientific queries
Name 89736 0
Dr Leesa Morton
Address 89736 0
Dept Anaethesia
Christchurch Hospital
Private Bag 4710
Christchurch
Country 89736 0
New Zealand
Phone 89736 0
+64 33640288
Fax 89736 0
Email 89736 0
leesa.morton@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this time we have made no decision around what data will be available. We are awaiting guidance from our organisational research governance group.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 960 0
Study protocol
Citation [1] 960 0
Link [1] 960 0
Email [1] 960 0
Other [1] 960 0
Type [2] 961 0
Ethical approval
Citation [2] 961 0
Link [2] 961 0
Email [2] 961 0
Other [2] 961 0
Type [3] 962 0
Informed consent form
Citation [3] 962 0
Link [3] 962 0
Email [3] 962 0
Other [3] 962 0
Summary results
No Results