ApneaPREOXNCT04767867
Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen
A study testing Pre-oxygenation in people with Apnea and Respiration; Arrest, run by University College Hospital Galway at 1 site in Ireland.
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. 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?
- Pre-oxygenation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2020to 13 Jan 2021
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen - a Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Apnea, Respiration; Arrest, Anesthesia
- Being tested
- Pre-oxygenation
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-oxygenationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Facemask oxygen (FM) | Experimental | 100% oxygen administered via facemask through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'breathe normally' Receives: Other: Pre-oxygenation |
| High-flow nasal oxygen (HFNO) | Active comparator | 100% oxygen administered via high-flow nasal cannulae at 50 L/min. Participant instructed to 'keep the mouth closed and breathe normally' Receives: Other: Pre-oxygenation |
| High-flow nasal oxygen plus mouthpiece oxygen (HFNO+MP) | Active comparator | 100% oxygen administered via high-flow nasal cannulae at 50 L/min. Additionally, 100% oxygen administered via mouthpice through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'keep the mouth closed and breathe normally'. Receives: Other: Pre-oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (5)
Arterial partial pressure of oxygen after pre-oxygenation.
As measured by blood gas analysis
Measured: At 3 minutes of pre-oxygenation
Arterial partial pressure of carbon dioxide change during pre-oxygenation
As measured by blood gas analysis
Measured: At 0 and 3 minutes
Change in arterial partial pressure of carbon dioxide during apnoea
As measured by blood gas analysis
Measured: At 0, 1, 2 minutes and each 2 minutes thereafter
Change in acid-base status during apnoea
As measured by blood gas analysis
Measured: At 0, 1, 2 minutes and each 2 minutes thereafter
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.
Measured: Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Aug 2020
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 84 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
- NCT04767867
- Sponsor's protocol ID
- Preox-HFNO
- Acronym
- PREOX
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 23 Feb 2021
- 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.
Publications
Lyons C, McElwain J, Coughlan MG, O'Gorman DA, Harte BH, Kinirons B, Laffey JG, Callaghan M. Pre-oxygenation with facemask oxygen vs high-flow nasal oxygen vs high-flow nasal oxygen plus mouthpiece: a randomised controlled trial. Anaesthesia. 2022 Jan;77(1):40-45. doi: 10.1111/anae.15556. Epub 2021 Aug 17.
PubMed 34402044
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04767867
- Acronym / sponsor ID
- PREOX / Preox-HFNO
- Conditions
- Apnea, Respiration; Arrest, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 23 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facemask oxygen (FM) | Experimental | Other: Pre-oxygenation100% oxygen administered via facemask through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'breathe normally' |
| High-flow nasal oxygen (HFNO) | Active comparator | Other: Pre-oxygenation100% oxygen administered via high-flow nasal cannulae at 50 L/min. Participant instructed to 'keep the mouth closed and breathe normally' |
| High-flow nasal oxygen plus mouthpiece oxygen (HFNO+MP) | Active comparator | Other: Pre-oxygenation100% oxygen administered via high-flow nasal cannulae at 50 L/min. Additionally, 100% oxygen administered via mouthpice through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'keep the mouth closed and breathe normally'. |
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 |
|---|---|---|
| Pre-oxygenationInduction 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. | Other | Facemask oxygen (FM), High-flow nasal oxygen (HFNO), High-flow nasal oxygen plus mouthpiece oxygen (HFNO+MP) |
Primary outcome
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.
5 secondary outcomes
Arterial partial pressure of oxygen after pre-oxygenation.
Time frame: At 3 minutes of pre-oxygenation
Arterial partial pressure of carbon dioxide change during pre-oxygenation
Time frame: At 0 and 3 minutes
Change in arterial partial pressure of carbon dioxide during apnoea
Time frame: At 0, 1, 2 minutes and each 2 minutes thereafter
Change in acid-base status during apnoea
Time frame: At 0, 1, 2 minutes and each 2 minutes thereafter
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.
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 23 Feb 2021.
- Derived from this study: PubMed 34402044Lyons C, McElwain J, Coughlan MG, O'Gorman DA, Harte BH, Kinirons B, Laffey JG, Callaghan M. Pre-oxygenation with facemask oxygen vs high-flow nasal oxygen vs high-flow nasal oxygen plus mouthpiece: a randomised controlled trial. Anaesthesia. 2022 Jan;77(1):40-45. doi: 10.1111/anae.15556. Epub 2021 Aug 17.
- 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 Pre-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 23 Feb 2021. 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. 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?
Time to oxygen desaturation (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767867, which also lists 1 linked publication.
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 23 Feb 2021.