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Published on: January 13, 2017
High-flow oxygen for children's airway surgery: randomised controlled trial protocol (HAMSTER)
Susan Humphreys1,2, Britta Sylvia von Ungern-Sternberg3,4, Justin Skowno5,6
1Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia susan.humphreys@uq.edu.au.
Insights
High-flow nasal oxygenation (HIGH-FLOW) may reduce hypoxaemic events during paediatric airway surgery compared to low-flow nasal oxygenation (LOW-FLOW). This trial investigates HIGH-FLOW
Area of Science:
- Pediatric Anesthesiology
- Respiratory Physiology
- Surgical Airway Management
Background:
- Hypoxemia is a common complication during tubeless upper airway surgery in children with abnormal airways.
- Balancing anesthesia depth, spontaneous breathing, and surgical visualization is challenging.
- High-flow nasal oxygenation (HIGH-FLOW) may improve safety but lacks comparative data against low-flow nasal oxygenation (LOW-FLOW).
Purpose of the Study:
- To compare the efficacy of HIGH-FLOW versus LOW-FLOW in reducing hypoxemic events during pediatric tubeless upper airway surgery.
- To determine if HIGH-FLOW can decrease the need for rescue oxygenation via positive pressure ventilation.
Main Methods:
- A multicenter, randomized controlled superiority trial (HAMSTER) involving 530 children (age >37 weeks to 16 years).
- Participants undergoing elective tubeless upper airway surgery were randomized to HIGH-FLOW or LOW-FLOW oxygenation post-induction.
- Primary outcome: incidence of hypoxemic events (SpO2 <90%) requiring rescue ventilation. Secondary outcomes: total hypoxemia time, cardiorespiratory events, and PICU admission.
Main Results:
- The study is ongoing, and results are pending publication.
- Data analysis will be conducted on an intention-to-treat basis.
Conclusions:
- The HAMSTER trial will provide crucial evidence on the effectiveness of HIGH-FLOW in pediatric airway surgery.
- Findings will inform clinical practice regarding optimal oxygenation strategies for this vulnerable patient population.
Introduction:
Hypoxaemia during anaesthesia for tubeless upper airway surgery in children with abnormal airways is common due to the complexity of balancing adequate depth of anaesthesia with maintenance of spontaneous breathing and providing an uninterrupted field of view of the upper airway for the surgeon. High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW). The aim is to investigate if use of HIGH-FLOW can reduce the number of hypoxaemic events requiring rescue oxygenation compared with LOW-FLOW. METHODS AND ANALYSIS: High-flow oxygen for children's airway surgery: randomised controlled trial (HAMSTER) is a multicentre, unmasked, randomised controlled, parallel group, superiority trial comparing two oxygenation techniques during anaesthesia. Children (n=530) aged >37 weeks to 16 years presenting for elective tubeless upper airway surgery who fulfil inclusion but not exclusion criteria will be randomised prior to surgery to HIGH-FLOW or LOW-FLOW post induction of anaesthesia. Maintenance of anaesthesia with HIGH-FLOW requires Total IntraVenous Anaesthesia (TIVA) and with LOW-FLOW, either inhalational or TIVA at discretion of anaesthetist. The primary outcome is the incidence of hypoxaemic events requiring interruption of procedure for rescue oxygenation by positive pressure ventilation and the secondary outcome includes total hypoxaemia time, adverse cardiorespiratory events and unexpected paediatric intensive care admission admission. Hypoxaemia is defined as Sp02 <90%. Analysis will be conducted on an intention-to-treat basis.
Ethics And Dissemination:
Ethical approval has been obtained by Children's Health Queensland Human Research Ethics Committee (HREC/18/QRCH/130). The trial commenced recruitment in 2018. The primary manuscript will be submitted for publication in a peer-reviewed journal.
Trial Registration Number:
The HAMSTER is registered with the Australia and New Zealand Clinical TrialsRegistry: ACTRN12618000949280.
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