Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001047684
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
27/09/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
27/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
SNIF study: Efficacy of nasally inhaled isopropyl alcohol for nausea in the intensive care unit: A randomised clinical trial
Scientific title
SNIF study: Efficacy of nasally inhaled isopropyl alcohol for nausea in the intensive care unit: A randomised clinical trial
Secondary ID [1] 308068 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SNIF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 327767 0
Nausea 327792 0
Vomiting 331369 0
Dry retching 331370 0
Condition category
Condition code
Oral and Gastrointestinal 324832 324832 0 0
Normal oral and gastrointestinal development and function
Public Health 328205 328205 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The participants will be supplied with three 70% Isopropyl Alcohol-soaked swabs (Briemar Nominees Pty Ltd, Victoria, Australia). The ICU nurse or clinician will educate the participant to hold the swab 1 to 2 cm from the nares and encourage them to inhale deeply through the nose as frequently as required to achieve nausea relief. Three new pads will be supplied every 15 minutes if required over the 60 minute intervention period. (i.e. up to a total of 12 swabs over the course of 60 minutes). Participants will be asked to rate their nausea on nausea VAS scoring sheet at 5, 15, 30, 45, and 60 minutes post-intervention. Nursing staff will also record the number of vomiting or dry retching episodes observed in the 60 minute period post-intervention. At 30 minutes and 60 minutes post-intervention, a 5-point Likert scale to measure overall satisfaction with the therapy will be recorded by the ICU nurse or clinician.
Intervention code [1] 324519 0
Treatment: Drugs
Comparator / control treatment
This is a non-randomised single group interventional trial. While there is no formal control group, each participant will be measured against whether or not the intervention avoids their need to receive standard therapy
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332649 0
The percentage (95% CI) of patients requiring intravenous ondansetron.
Timepoint [1] 332649 0
upto 60 minutes post commencement of intervention
Secondary outcome [1] 414230 0
Delta nausea visual analogue scale score
Timepoint [1] 414230 0
at 5, 15, 30, 45 and 60 mins post commencement of intervention
Secondary outcome [2] 414231 0
New episodes of vomiting or dry retching will be documented on the study case report form by the bedside nurse.
Timepoint [2] 414231 0
Upto 60 minutes post commencement of intervention
Secondary outcome [3] 414232 0
Percentage (95% CI) of patients requiring escalation to a second-line intravenous anti-emetic. This will be documented on the study case report form by the bedside nurse.
Timepoint [3] 414232 0
Up to 60 minutes post commencement of intervention
Secondary outcome [4] 414233 0
Patient satisfaction Likert scale
Timepoint [4] 414233 0
at 30 minutes and 60 minutes post commencement of intervention

Eligibility
Key inclusion criteria
Patients admitted to the Intensive Care Unit at the Royal Adelaide Hospital will be recruited if they meet all of the following inclusion Criteria:
1. Reports symptom of nausea or witnessed episode of vomiting / dry retching
2. Would be initiated on PONV protocol management
3. Aged 18 or above
4. Self-ventilating
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
1. Allergy to isopropyl alcohol
2. Allergy to ondansetron
3. Inability to breathe through the nose
4. Inability to give informed consent
5. Mental or physical state precluding accurate assessment of nausea/ satisfaction scores
6. Administration of antiemetic medication within the preceding 8 hours
7. Administration of medication known to produce nausea when exposed to alcohol within the preceding 24 hours (e.g. Metronidazole, Disulfiram, Tinidazole, Trimethoprim-Sulfamethoxazole)
8. Symptoms of nausea or vomiting for > 24 hours
9. Pregnancy

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We propose a number needed to treat of 10 critically ill patients would be clinically significant for a cheap, safe, readily available intervention to reduce exposure to intravenous anti-emetics. Assuming a baseline conventional anti-emetic exposure of 100% for patients reporting nausea in the ICU, we propose that reducing exposure to rescue intravenous antiemetics by 10% (95%CI 5-15%) will be clinically significant and justify a subsequent implantation trial. As the effect size is not known in the critically ill, we have taken a conservative approach and propose a sample size of 60 patients.

Anonymised data will be analysed by biostatistican Associate Professor Mark Finnis. Demographic data will be summarized with descriptive statistics. The main effect will be the point estimate (95% confidence interval, CI) for the proportion of patients avoiding treatment escalation. Mean VAS scores (95%CI) over time will displayed as temporal plots, with between treatment groups assessed by mixed models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
15/10/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
15/01/2025
Actual
Sample size
Target
60
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23242 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 38612 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 312324 0
Hospital
Name [1] 312324 0
Intensive Care Unit, Royal Adelaide Hospital
Country [1] 312324 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Road,Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 313877 0
None
Name [1] 313877 0
Address [1] 313877 0
Country [1] 313877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311691 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 311691 0
Ethics committee country [1] 311691 0
Australia
Date submitted for ethics approval [1] 311691 0
10/10/2022
Approval date [1] 311691 0
11/05/2023
Ethics approval number [1] 311691 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122014 0
Dr Palash Kar
Address 122014 0
Intensive Care Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 122014 0
Australia
Phone 122014 0
+61 401 878 997
Fax 122014 0
Email 122014 0
[email protected]
Contact person for public queries
Name 122015 0
Mark Plummer
Address 122015 0
Level 4G751, Intensive Care Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 122015 0
Australia
Phone 122015 0
+61 8 7074 1800
Fax 122015 0
Email 122015 0
[email protected]
Contact person for scientific queries
Name 122016 0
Mark Plummer
Address 122016 0
Level 4G751, Intensive Care Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 122016 0
Australia
Phone 122016 0
+61 8 7074 1800
Fax 122016 0
Email 122016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be made available upon direct request to the primary investigator and reviewed case-by-case by the management committee.
When will data be available (start and end dates)?
Data will be made available from the time of publication up until 15 years post study commencement in-keeping with data management outlined in the ethics application.
Available to whom?
Anyone will be eligible to apply.
Available for what types of analyses?
Scientific analyses
How or where can data be obtained?
Data will not be placed in a public repository but will be directly sent to approved individuals or institutions after consideration of their application to PI Associate Professor Mark Plummer ([email protected]).


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.