ApneaApox-HFNONCT05124093
The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea
A study testing Apnoeic oxygenation in people with Apnea and Respiration; Arrest, run by University College Hospital Galway at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Respiration; Arrest, Anesthesia
- What is being tested?
- Apnoeic oxygenation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteIreland
- Study dates
- 22 Nov 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- ASA 1 or 2
- Receiving a general anaesthetic for non-emergent surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Apnoeic Oxygenation With No-flow vs High-flow vs Ultra High-flow Nasal Oxygen
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.
Read the 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.
- Conditions
- Apnea, Respiration; Arrest, Anesthesia
- Being tested
- Apnoeic oxygenation
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnoeic oxygenationProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| Apnoea without apnoeic oxygenation | Placebo comparator | High-flow nasal oxygen administration ceases at the onset of apnoea. Receives: Procedure: Apnoeic oxygenation |
| Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO) | Active comparator | 100% oxygen is administered via high-flow nasal cannulae at 70L/min from the onset of apnoea until four minutes of apnoea has completed. Receives: Procedure: Apnoeic oxygenation |
| Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO) | Active comparator | 100% oxygen is administered via high-flow nasal cannulae at 120L/min from the onset of apnoea until four minutes of apnoea has completed. Receives: Procedure: Apnoeic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rise in arterial partial pressure of carbon dioxide
The 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.
Measured: Between 1 and 4 minutes of apnoea
Secondary outcomes (5)
Partial pressure of oxygen during apnoea
As measured by blood gas analysis
Measured: Following high-flow nasal oxygen administration
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.
Measured: Immediately after the intervention
Change in carbon dioxide elevation before and after HFNO administration
As measured by blood gas analysis
Measured: Between 3 and 5 minutes of apnoea
Carbon dioxide elevation during the first minute of apnoea
As measured by blood gas analysis
Measured: Between 0 and 1 minute of apnoea
Change in acid-base status during apnoea
As measured by blood gas analysis
Measured: At 1 minute intervals during apnoea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start22 Nov 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Laffey, University College Hospital Galway
- Investigators
- Michael Callaghan, MB BCh BAO, Principal investigator, Consultant Anaesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124093
- Sponsor's protocol ID
- CA2361
- Acronym
- Apox-HFNO
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sharing of anonymised patient-specific data that underlie results in any publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Apnoeic Oxygenation With No-flow vs High-flow vs Ultra High-flow Nasal Oxygen
- ClinicalTrials.gov ID
- NCT05124093
- Acronym / sponsor ID
- Apox-HFNO / CA2361
- Conditions
- Apnea, Respiration; Arrest, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apnoea without apnoeic oxygenation | Placebo comparator | Procedure: Apnoeic oxygenationHigh-flow nasal oxygen administration ceases at the onset of apnoea. |
| Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO) | Active comparator | Procedure: Apnoeic oxygenation100% oxygen is administered via high-flow nasal cannulae at 70L/min from the onset of apnoea until four minutes of apnoea has completed. |
| Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO) | Active comparator | Procedure: Apnoeic oxygenation100% oxygen is administered via high-flow nasal cannulae at 120L/min from the onset of apnoea until four minutes of apnoea has completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- ASA 1 or 2
- Receiving a general anaesthetic for non-emergent surgery
Key exclusion criteria (8 listed)
- ASA score ≥3
- BMI ≥ 30 kg/m2
- Nasal obstruction
- Baseline SpO2 ≤95% on room air
- Anticipated difficult airway management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apnoeic oxygenationAfter 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%. | Procedure or surgery | Apnoea without apnoeic oxygenation, Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO), Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO) |
Primary outcome
Rise in arterial partial pressure of carbon dioxide
Time frame: Between 1 and 4 minutes of apnoea
The 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.
5 secondary outcomes
Partial pressure of oxygen during apnoea
Time frame: Following high-flow nasal oxygen administration
Time to oxygen desaturation
Time frame: Immediately after the intervention
Change in carbon dioxide elevation before and after HFNO administration
Time frame: Between 3 and 5 minutes of apnoea
Carbon dioxide elevation during the first minute of apnoea
Time frame: Between 0 and 1 minute of apnoea
Change in acid-base status during apnoea
Time frame: At 1 minute intervals during apnoea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: Yes. The sharing of anonymised patient-specific data that underlie results in any publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Callaghan, MB BCh BAO principal investigator
Consultant Anaesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apnoeic oxygenation in people with Apnea and Respiration; Arrest, run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rise in arterial partial pressure of carbon dioxide (time frame: Between 1 and 4 minutes of apnoea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.