Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001341718
Ethics application status
Not yet submitted
Date submitted
18/09/2013
Date registered
9/12/2013
Date last updated
9/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of video during consent reduce anxiety during awake fibreoptic intubation?
Scientific title
In patients with potentially difficult airways, does the use of video reduce anxiety level during awake fibreoptic intubation
Secondary ID [1] 283239 0
Nil
Universal Trial Number (UTN)
Trial acronym
AFOI video
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potential Difficult Airways 290105 0
Condition category
Condition code
Anaesthesiology 290484 290484 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Video showing procedure of awake fibreoptic intubation prior to the procedure during the consent process. The duration of the video is less than 5 minutes.

The participants in the intervention group will receive the leaflet and verbal information in addition to the video
Intervention code [1] 287964 0
Other interventions
Comparator / control treatment
Leaflet information on awake fibreoptic intubation. Verbal information will be provided as part of the consent process for the procedure
Control group
Active

Outcomes
Primary outcome [1] 290508 0
Reduction in anxiety
The outcome is assessment by a score out of 10. 10 being very anxious and 0 being not anxious at all
Timepoint [1] 290508 0
The assessments will be done on Day 1 post procedure and Day 7 post procedure
Primary outcome [2] 290549 0
Increase Satisfaction
The outcome is assessment by a score out of 10. 10 being very satisfied and 0 being not satisfied at all
Timepoint [2] 290549 0
Day 1 and Day 7 post procedure
Secondary outcome [1] 304674 0
complications to awake fibreoptic as observed and documented by the Anaesthetist.
They include: sore throat, nasal bleeding, vomiting, desaturation, voice change, cough, headache
Timepoint [1] 304674 0
during procedure

Eligibility
Key inclusion criteria
Patients identified as having potenitally difficult airways by the anaesthetist for surgeries that will require intubation for patient safety
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Children
Refusal
Patient who are unable to consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287978 0
Self funded/Unfunded
Name [1] 287978 0
N/A - unfunded
Country [1] 287978 0
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba
QLD
4102
Country
Australia
Secondary sponsor category [1] 286700 0
None
Name [1] 286700 0
Address [1] 286700 0
Country [1] 286700 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289908 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 289908 0
Ethics committee country [1] 289908 0
Australia
Date submitted for ethics approval [1] 289908 0
19/09/2013
Approval date [1] 289908 0
Ethics approval number [1] 289908 0

Summary
Brief summary
Awake fibreoptic intubation is a method to enable intubation in patient with difficult airways. To ensure safety of the patient, awake fibreoptic intubation may be required. Previous studies have shown that this process can be a cause of anxiety in patients. The aim of this study is to investigate whether the use of a video to demonstrate the process will alleviate anxiety in this group of patient.
The study will be a randomised controlled trial. The control group would have the process explained to them verbally and in the form of a leaflet. The study group will, in addition to verbal and leaflet, be shown a video on the process. A questionnaire will be used prior to the explaination to assess the level of anxiety and the questionnaire will be repeated after the operation twice
The data collected will be analysed using appropriate statistical method.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43022 0
Dr Nicole Fairweather
Address 43022 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD
4102
Country 43022 0
Australia
Phone 43022 0
+61731762822
Fax 43022 0
Email 43022 0
[email protected]
Contact person for public queries
Name 43023 0
Nicole Fairweather
Address 43023 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD
4102
Country 43023 0
Australia
Phone 43023 0
+61731762822
Fax 43023 0
Email 43023 0
[email protected]
Contact person for scientific queries
Name 43024 0
Nicole Fairweather
Address 43024 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD
4102
Country 43024 0
Australia
Phone 43024 0
+61731762822
Fax 43024 0
Email 43024 0
[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
No additional documents have been identified.