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The use of high flow nasal oxygen device for pre-oxygenation in neurosurgical patients: a randomised controlled trial

The use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for pre-oxygenation in neurosurgical patients: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000356369
Enrollment
50
Registered
2017-03-08
Start date
2017-03-16
Completion date
2017-07-06
Last updated
2018-02-19

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

Conditions

None listed

Brief summary

In this study, we plan to compare two different techniques of supplying oxygen to patients before they go to sleep under general anaesthesia for neurosurgical operation. The usual way of doing this procedure involves breathing oxygen through a facemask. In this study, a computer program will randomly allocate them to receive either oxygen via the facemask, or to have humidified oxygen delivered at high flow via two prongs in the nose. The study aims to test if the nasal oxygen method keeps oxygen levels higher compared to the usual practice, which is oxygen via the facemask. The nasal oxygen method has been used extensively in other parts of the hospital for many years. It has now become increasingly popular to be used in the operating theatre. However, there are limited studies on the use of this device in anaesthetic setting.

Interventions

Intervention group will receive Optiflow Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) as their device for pre-oxygenation. Oxygen will be delivered through two nasal prongs. The procedure will be carried out by the treating anaesthetist. Pre-oxygenation phase: After the patient is placed at a “sniffing” position with a pillow under the head, pre-oxygenation is commenced with appropriate monitoring, resuscitation equipment and assistance in accordance with the Australian

Intervention group will receive Optiflow Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) as their device for pre-oxygenation. Oxygen will be delivered through two nasal prongs. The procedure will be carried out by the treating anaesthetist. Pre-oxygenation phase: After the patient is placed at a “sniffing” position with a pillow under the head, pre-oxygenation is commenced with appropriate monitoring, resuscitation equipment and assistance in accordance with the Australian and New Zealand College of the Anaesthetists’ guidelines. Bispectral index (BIS) monitor will also be put on the patient. Oxygen is delivered via THRIVE device, which will be turned on for at least 10 minutes before the start of the operation to ensure the air is humidified sufficiently. Patients will be put on a THRIVE device with oxygen (FiO2 of 1.0) delivering at 30 L/min for 30 seconds and then increased to 50 L/min. The humidity and temperature will follow its default setting which is at 37 degree celsius and 100% humidity. After 5 minutes of pre-oxygenation, anaesthetic induction will then begin. THRIVE device will continue to delivery high flow oxygen at 50L/min throughout pre-oxygenation until successful intubation. There will be no pause until we secure the airway. Induction phase: Propofol will be administered using target controlled infusion (TCI) technique aiming to maintain BIS between 40-60. Opioids will be given at the discretion of the treating anaesthetist. Nerve stimulator will then be calibrated and train of four count (TOF) will commence every 20 seconds. Rocuronium will be given at 1.0mg/kg. Oxygenation via the THRIVE device is continued after patient loses consciousness. Upper airway patency needs to be maintained to ensure adequate apoeic ventilation. If there is any sign of desaturation (SpO2 < 95%) during apoeic oxygenation, the treating anaesthetist is allowed to manage the airway at his/her own discretion, including conversion to bag and mask ventilation if necessary. Airway maneouvres, such as chin lift and jaw thrust; and airway adjuncts, such as oropharyngeal airway will be used at the discretion of the anaesthetist. Once the TOF = 0, the patient will be intubated. After successful intubation, THRIVE will be discontinued and mechanical ventilation will commence. If an unexpected intubation is encountered, the anaesthetist can convert to facemask ventilation if necessary. After this time, the anaesthetist may modify their anaesthetic technique at their discretion.

Sponsors

Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults requiring general anaesthetics and arterial line for neurosurgical procedures. - Adult patients aged greater than or equal to 18 years - ASA 1-3 - Able to give informed consent - Having neurosurgical operation, requiring general anaesthesia for asleep oro-tracheal intubation - Require arterial line insertion pre-operatively

Exclusion criteria

- Non-English speaking - Risk of aspiration - BMI > 35 - Known or anticipated difficult airway - Patients require awake fibre-optic intubation, gas induction or rapid sequence induction - Known allergy to propofol or rocuronium - Raised intracranial pressure (clinically or radiologically) - Known basal skull fracture - Active nasal bleed

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026