Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000426583
Ethics application status
Approved
Date submitted
20/03/2024
Date registered
8/04/2024
Date last updated
8/04/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Objective Pre-oxygenation in paediatric EmeRgent Airway management (OPERA): assessing the efficacy of pre-oxygenation techniques - A prospective cohort study.
Scientific title
Objective Pre-oxygenation in paediatric EmeRgent Airway management (OPERA): assessing the efficacy of pre-oxygenation techniques - A prospective cohort study.
Secondary ID [1] 309980 0
None
Universal Trial Number (UTN)
Trial acronym
OPERA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency intubation 330470 0
Condition category
Condition code
Respiratory 327322 327322 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a once-off intervention performed at the hospital face to face by a research clinician. No ongoing involvement or follow up is required.
When the patient is ready, pre-experiment measurements will be taken & documented - these are SpO2, FeO2, ORi which are all non-invasive measurements of oxygen levels in the lungs and blood. The patient will then have oxygen applied using each of the techniques for a period of 3 minutes each. At the end of each period the FeO2, SpO2 and ORi will be re-recorded.

After this monitoring of ORi will continue until it reaches 0. The time take to return to 0 will be documented. A further washout period of not less than 15 minutes will then be provided before the next technique is undertaken.

The four preoxygenation techniques to be investigated are:
• Non-rebreather mask with 15L/min of oxygen flow
• Standard nasal prongs with 15L/min of oxygen flow
• Nasal high flow cannuale with 2L/kg/min of oxygen flow and FiO2 100%
• Anaesthetic t-piece with mask (applied with adequate seal) with age appropriate flow and FiO2 100%

Each device will be applied to the participant when they are seated or lying down after being appropriately sized using sizing guidelines and clinical assessment to ensure a good seal is achieved. A clinician will remain with each participant to ensure adherence for the duration

It is expected the total duration will be 1-1.5 hours
Intervention code [1] 326400 0
Prevention
Intervention code [2] 328310 0
Treatment: Other
Comparator / control treatment
All four techniques will be compared to each other, with the main comparator being anaesthetic t-piece with mask. Each technique will be assessed for the same duration
Control group
Active

Outcomes
Primary outcome [1] 335192 0
The primary outcome is the proportion of patients with an FeO2 > 90% at the end of 3 minutes of preoxygenation which is assessed using a gas sampling line attached to each device.
Timepoint [1] 335192 0
3 minutes for each intervention (4 interventions assessed for each participant)
Secondary outcome [1] 423422 0
Measured FeO2 at the end of 3 minutes of preoxygenation which is assessed using a gas sampling line attached to each device.
Timepoint [1] 423422 0
3 minutes for each intervention (4 interventions assessed for each participant)
Secondary outcome [2] 423423 0
FeO2 value at 3 minutes of preoxygenation which is assessed using a gas sampling line attached to each device.
Timepoint [2] 423423 0
3 minutes for each intervention (4 interventions assessed for each participant)
Secondary outcome [3] 423424 0
ORi at 3 minutes of preoxygenation which is measured using a pulse oximeter
Timepoint [3] 423424 0
3 minutes for each intervention (4 interventions assessed for each participant)
Secondary outcome [4] 423425 0
Time taken to return to ORi = 0 after removal of pre-oxygenation which is measured using a pulse oximeter
Timepoint [4] 423425 0
To be measured until ORi returns to 0

Eligibility
Key inclusion criteria
Each participant must meet all the following criteria to be enrolled in this study:
• Less than 11 years old at the time of recruitment
• Have no current illnesses or infections
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
Minimum age
No limit
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
• Known cyanotic congenital heart disease
• Known chronic lung disease
• Acute respiratory illness
• Coryzal symptoms within preceding 7 days
• Fever or oxygen requirement within the preceding 7 days

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Chi-squared test to explore the association between the technique used and the proportion of children with an FeO2>90% at 3 minutes. If the chi-squared test returns a significant p-value, series of two-sample proportion tests will be undertaken comparing the gold standard technique to each other technique, adjusting for multiple comparisons using Bonferroni’s correction. Exploratory analysis will be undertaken by age group to ascertain if there is differences in outcome between these groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314155 0
Hospital
Name [1] 314155 0
Gold Coast University Hospital
Country [1] 314155 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Health
Address
1 Hospital Blvd, Southport, 4215
Country
Australia
Secondary sponsor category [1] 316074 0
None
Name [1] 316074 0
Address [1] 316074 0
Country [1] 316074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313289 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313289 0
Ethics committee country [1] 313289 0
Australia
Date submitted for ethics approval [1] 313289 0
02/06/2023
Approval date [1] 313289 0
20/11/2023
Ethics approval number [1] 313289 0
HREC/23/QCHQ/57126

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

Contacts
Principal investigator
Name 127618 0
Dr Kayla Foord
Address 127618 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, Gold Coast, QLD 4215
Country 127618 0
Australia
Phone 127618 0
+61 466316325
Fax 127618 0
Email 127618 0
[email protected]
Contact person for public queries
Name 127619 0
Kayla Foord
Address 127619 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, Gold Coast, QLD 4215
Country 127619 0
Australia
Phone 127619 0
+61 1300744284
Fax 127619 0
Email 127619 0
[email protected]
Contact person for scientific queries
Name 127620 0
Shane George
Address 127620 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, Gold Coast, QLD 4215
Country 127620 0
Australia
Phone 127620 0
+61 07 56870000
Fax 127620 0
Email 127620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.