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The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea

A Randomised Controlled Trial of Apnoeic Oxygenation With No-flow vs High-flow vs Ultra High-flow Nasal Oxygen

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05124093
Acronym
Apox-HFNO
Enrollment
114
Registered
2021-11-17
Start date
2021-11-22
Completion date
2022-05-25
Last updated
2022-07-11

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

Apnoeic oxygenation refers to oxygenation that occurs through the insufflation of oxygen into the lungs in the absence spontaneous respiration or positive pressure ventilation. It is used to extend the time to desaturation at induction of anaesthesia and as a primary oxygenation technique during airway surgery. The impact of high-flow nasal oxygen flow rate selection on gas exchange is poorly understood. Participants in this study will be randomised to receive a certain nasal oxygen flow rate during apnoea and its effect on gas exchange will be measured by blood gas analysis.

Detailed description

Apnoeic oxygenation with high-flow nasal oxygen has been proposed to result in carbon dioxide clearance. However, this has been poorly quantified. This study will compare use of nasal oxygen at different flow rates during apnoea with that of a control that does not receive nasal oxygen. Participants are anaesthetised after standardised pre-oxygenation with high-flow nasal oxygen, after which they will receive one of three nasal oxygen flow rates (0, 70, 120 L/min). The rate of carbon dioxide elevation will be measured by arterial blood gas analysis after the onset of apnoea and compared between the three groups to discern the relative rates of carbon dioxide clearance after the first minute of apnoea. The effect of nasal oxygen flow rate on oxygenation will also be measured.

Interventions

After 2mins 45 seconds of pre-oxygenation with high-flow nasal oxygen at Fio2 1.0 at 50L/min, anaesthesia is induced with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions administered until study conclusion. At the onset of apnoea, 1mg/kg rocuronium administered. Jaw thrust performed. High-flow nasal oxygen adjusted to the randomised flow rate. Videolaryngoscopy after 1 minute of apnoea. Airway patency maintained. Tracheal intubation after 4 minutes of apnoea. Positive pressure ventilation commenced at Spo2 92%. Failure to obtain view of glottis with videolaryngoscope 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 each minute of apnoea until six minutes of apnoea, and every two minutes of apnoea thereafter, until Spo2 92%.

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 in preceding 14 days.

Design outcomes

Primary

MeasureTime frameDescription
Rise in arterial partial pressure of carbon dioxideBetween 1 and 4 minutes of apnoeaThe rate of rise of the partial pressure of carbon dioxide between 60 seconds and 240 seconds of apnoea as measured by arterial blood gas analysis.

Secondary

MeasureTime frameDescription
Partial pressure of oxygen during apnoeaFollowing high-flow nasal oxygen administrationAs measured by blood gas analysis
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.
Change in carbon dioxide elevation before and after HFNO administrationBetween 3 and 5 minutes of apnoeaAs measured by blood gas analysis
Carbon dioxide elevation during the first minute of apnoeaBetween 0 and 1 minute of apnoeaAs measured by blood gas analysis
Change in acid-base status during apnoeaAt 1 minute intervals during apnoeaAs measured by blood gas analysis

Countries

Ireland

Outcome results

None listed

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