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Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen

Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen - a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04767867
Acronym
PREOX
Enrollment
84
Registered
2021-02-23
Start date
2020-08-01
Completion date
2021-01-13
Last updated
2021-02-23

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

Conditions

Anesthesia, Apnea, Respiration; Arrest

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.

Interventions

Induction of anaesthesia after 2mins 45 seconds of pre-oxygenation with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions commenced until study conclusion. Positive pressure ventilation commenced at Sp02 92%. Failure to intubate the patient during the first minute of apnoea results in withdrawal from the study. Blood samples obtained from an arterial catheter immediately prior to commencing pre-oxygenation, after 90 and 180 seconds of pre-oxygenation, after one minute of apnoea, and every two minutes during the apnoeic period.

Sponsors

University College Hospital Galway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to oxygen desaturationImmediately after the interventionThe time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.

Secondary

MeasureTime frameDescription
Arterial partial pressure of oxygen after pre-oxygenation.At 3 minutes of pre-oxygenationAs measured by blood gas analysis
Arterial partial pressure of carbon dioxide change during pre-oxygenationAt 0 and 3 minutesAs measured by blood gas analysis
Change in arterial partial pressure of carbon dioxide during apnoeaAt 0, 1, 2 minutes and each 2 minutes thereafterAs measured by blood gas analysis
Change in acid-base status during apnoeaAt 0, 1, 2 minutes and each 2 minutes thereafterAs measured by blood gas analysis
Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxideEtco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.The EtCO2 value used for comparison is the highest value recorded during the first five respiratory cycles by manual ventilation with the adjustable pressure-limiting valve set at 20cmH20.

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026