Clinical trial NCT04767867: Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen
Official title: Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea
Respiration; Arrest
Anesthesia
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-oxygenation increases oxygen reserves in the body to reduce the likelihood of oxygen desaturation on induction of general anaesthesia. Pre-oxygenation with facemask is the commonest method method of pre-oxygenation. High-flow nasal oxygen is a newer alternative. This study randomises participants to receive pre-oxygenation by one of three methods: facemask, high-flow nasal oxygen, high-flow nasal oxygen plus mouthpiece.

Detailed description: The administration of supplemental oxygen prior to induction of anaesthesia is known as pre-oxygenation. Pre-oxygenation increases oxygen reserves in the body with the purpose of delaying the time until oxygen desaturation after breathing stops (apnoea) following the administration of an anaesthetic. In the last decade, clinicians have begun utilising high-flow nasal oxygen for pre-oxygenation. However, the rationale for this is based largely on its ability to achieve ongoing oxygenation after the onset of apnoea (apnoeic oxygenation). This study isolates oxygen administration with high-flow nasal oxygen to the period when the person is breathing, without ongoing oxygen administration during the apnoea period, to quantify its effects during the pre-oxygenation period only. A third group of participants breathes oxygen through a mouthpiece in addition to receiving oxygen via high-flow nasal cannulae. The effect of these pre-oxygenation methods will be measured by the time taken until oxygen saturation levels decline to the lower end of the normal range (92%), along with other parameters such as blood oxygen levels.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* ASA 1 or 2
* Receiving a general anaesthetic for non-emergent surgery

Exclusion Criteria:

* ASA score ≥3
* BMI ≥ 30 kg/m2
* Nasal obstruction
* Baseline SpO2 ≤95% on room air
* Anticipated difficult airway management
* Requirement for awake intubation
* Pregnancy
* Positive PCR test for coronavirus.

Primary outcomes:
measure: Time to oxygen desaturation
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Arterial partial pressure of oxygen after pre-oxygenation.
timeFrame: At 3 minutes of pre-oxygenation
measure: Arterial partial pressure of carbon dioxide change during pre-oxygenation
timeFrame: At 0 and 3 minutes
measure: Change in arterial partial pressure of carbon dioxide during apnoea
timeFrame: At 0, 1, 2 minutes and each 2 minutes thereafter
measure: Change in acid-base status during apnoea
timeFrame: At 0, 1, 2 minutes and each 2 minutes thereafter
measure: Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxide
timeFrame: Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University Hospital Galway
Study officials:
affiliation: Consultant Anaesthesiologist
name: Michael Callaghan, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyons C, McElwain J, Coughlan MG, O'Gorman DA, Harte BH, Kinirons B, Laffey JG, Callaghan M. Pre-oxygenation with facemask oxygen vs high-flow nasal oxygen vs high-flow nasal oxygen plus mouthpiece: a randomised controlled trial. Anaesthesia. 2022 Jan;77(1):40-45. doi: 10.1111/anae.15556. Epub 2021 Aug 17.