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Objective Pre-oxygenation in paediatric EmeRgent Airway management (OPERA): assessing the efficacy of pre-oxygenation techniques - A prospective cohort study.

Objective Pre-oxygenation in paediatric EmeRgent Airway management (OPERA): assessing the efficacy of pre-oxygenation techniques - A prospective cohort study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000426583
Acronym
OPERA
Enrollment
90
Registered
2024-04-08
Start date
2024-04-30
Completion date
2024-11-30
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the adequacy of pre-oxygenation through the techniques identified to be used in a recent survey of clinicians in Australia and New Zealand in healthy children. The results of this study will inform a follow-on study investigating effective pre-oxygenation techniques in critically unwell patients in the intensive care unit and emergency department

Interventions

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-r

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

Sponsors

Gold Coast Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
No minimum to 10 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026