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

Anesthesia Clinical Trial

— PREOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767867
• Other study ID #: Preox-HFNO
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: February 2021
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Apnea
• Respiration; Arrest

Intervention

Other:
• Pre-oxygenation
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.

Locations

Country	Name	City	State
Ireland	University Hospital Galway	Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to oxygen desaturation	The time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.	Immediately after the intervention
Secondary	Arterial partial pressure of oxygen after pre-oxygenation.	As measured by blood gas analysis	At 3 minutes of pre-oxygenation
Secondary	Arterial partial pressure of carbon dioxide change during pre-oxygenation	As measured by blood gas analysis	At 0 and 3 minutes
Secondary	Change in arterial partial pressure of carbon dioxide during apnoea	As measured by blood gas analysis	At 0, 1, 2 minutes and each 2 minutes thereafter
Secondary	Change in acid-base status during apnoea	As measured by blood gas analysis	At 0, 1, 2 minutes and each 2 minutes thereafter
Secondary	Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxide	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.	Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.