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Completed

NCT Number: NCT04767867

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Galway

Galway, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-oxygenation

Other

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.

Primary outcomes

  1. Time to oxygen desaturation

    Time frame: Immediately after the intervention

    The time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.

Secondary outcomes

  1. Arterial partial pressure of oxygen after pre-oxygenation.

    Time frame: At 3 minutes of pre-oxygenation

    As measured by blood gas analysis

  2. Arterial partial pressure of carbon dioxide change during pre-oxygenation

    Time frame: At 0 and 3 minutes

    As measured by blood gas analysis

  3. Change in arterial partial pressure of carbon dioxide during apnoea

    Time frame: At 0, 1, 2 minutes and each 2 minutes thereafter

    As measured by blood gas analysis

  4. Change in acid-base status during apnoea

    Time frame: At 0, 1, 2 minutes and each 2 minutes thereafter

    As measured by blood gas analysis

  5. Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxide

    Time frame: Etco2 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.

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Registry information

Official study title

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

Acronym: PREOX

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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