Apneic OxygenationPhase 4NCT02755389
Apneic Oxygenation Via Nasal Cannulae: 15 L/Min vs High-Flow
A Phase 4 study testing 0 L/min oxygen via conventional nasal cannulae, 15 L/min oxygen via conventional nasal cannulae and 60 L/min oxygen via high-flow nasal cannulae in people with Apneic Oxygenation, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
This is a randomized clinical trial investigating the utility of apneic oxygenation via nasal cannulae in the post-induction setting for the purpose of prolonging the safe apneic time. Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Apneic Oxygenation
- What is being tested?
- 0 L/min oxygen via conventional nasal cannulae, 15 L/min oxygen via conventional nasal cannulae and 60 L/min oxygen via high-flow nasal cannulae
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to 22 Jun 2018
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Physical Status Classification 1 to 3
- Body Mass Index 28 to 35
- Elective surgery under general anesthesia
Who cannot join
- Evidence of difficult airway management (from patient history or clinical examination)
- Features suggestive of difficult bag mask ventilation
- Significant uncontrolled gastroesophageal reflux disease
- Significant respiratory disease (including severe asthma or chronic obstructive pulmonary disease, oxygen dependency, pulmonary hypertension, identified by pulmonary function tests or inability to climb one flight of stairs)
- Significant cardiac disease (ischemic heart disease, severe valvular disease, severe arrhythmia, congestive heart failure, ejection fraction < 50%, inability to climb one flight of stairs)
- Inability to lie flat (skeletal deformities, orthopnea)
Show all 17Show fewer
- Hemoglobin < 100 g/L
- Pregnancy
- Neuromuscular disorder
- Known or suspected cervical spine instability
- Patients undergoing neurosurgical procedures
- Any clinical or radiological evidence of increased intracranial pressure
- Any expected requirement for rapid sequence intubation
- Allergy to any of the agents used for induction of general anesthesia in the study
- Contraindication to insertion of radial artery cannula
- Uncorrected coagulopathy
- Significant nasal obstruction
Trial locations and contacts
1 site in 1 country.
Canada1 site
Halifax Infirmary, QEII Health Sciences Centre
Halifax, Nova Scotia
About this study
This is a randomized clinical trial investigating the utility of apneic oxygenation via nasal cannulae in the post-induction setting for the purpose of prolonging the safe apneic time. Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min group. The primary outcome will be the difference in the partial pressure of oxygen in arterial blood (PaO2) between groups throughout the nine-minute apneic period.
Read the detailed description
Airway management can be a life saving therapy. One major complication that may occur during airway management is a lack of oxygen in the blood. If severe or prolonged, this lack of oxygen can result in permanent brain damage, damage to other vital organs or even death. Strategies already exist to help prevent a lack of oxygen in the blood (hypoxemia), however research involving new ways to oxygenate patients may help to minimize the chance of hypoxemia during airway management. Apneic oxygenation is a novel method of delivering oxygen to a patient despite a lack of active respiration (i.e. the patient is not breathing on their own and the investigators are not providing the patient an artificial breath). The simplest and least invasive method to provide apneic oxygenation is the application of oxygen through nasal cannulae during airway management. Several different techniques to provide apneic oxygenation via nasal cannulae have been previously described(1-3), however randomized trials comparing these methods do not exist. This study will examine the change over time of the amount of oxygen dissolved in the blood (PaO2) in each of the three treatment groups: a control group (no apneic oxygenation), a 15 L/min group and a 60 L/min group. This data will help to determine the extent of benefit apneic oxygenation provides in this setting.
- Conditions
- Apneic Oxygenation
- Being tested
- 0 L/min oxygen via conventional nasal cannulae, 15 L/min oxygen via conventional nasal cannulae, 60 L/min oxygen via high-flow nasal cannulae
- Keywords
- Tracheal intubation, High flow nasal oxygen, Airway management, Apneic oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 L/min oxygen via conventional nasal cannulaeDrug
Also called 0 L/min apneic oxygenation
Patients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be no oxygen flowing through the cannulae in this group during the study.
15 L/min oxygen via conventional nasal cannulaeDrug
Also called 15 L/min apneic oxygenation
Patients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 15 L/min of oxygen flowing through the cannulae in this group during the study.
60 L/min oxygen via high-flow nasal cannulaeDrug
Also called 60 L/min apneic oxygenation
Patients will have high-flow nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 60 L/min of oxygen flowing through the cannulae in this group during the study.
| Study group | Role | What they receive |
|---|---|---|
| 0 L/min | Placebo comparator | These participants will receive 0 L/min oxygen via conventional nasal cannulae during the apneic period. Receives: Drug: 0 L/min oxygen via conventional nasal cannulae |
| 15 L/min | Experimental | These participants will receive 15 L/min oxygen via conventional nasal cannulae during the apneic period. Receives: Drug: 15 L/min oxygen via conventional nasal cannulae |
| 60 L/min | Experimental | These participants will receive 60 L/min oxygen via high-flow nasal cannulae during the apneic period. Receives: Drug: 60 L/min oxygen via high-flow nasal cannulae |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2: repeated measures every 90 seconds after induction
data collected from serial arterial blood gas measurements
Measured: 0-9 minutes after induction
Secondary outcomes (4)
Partial pressure of carbon dioxide in arterial blood (PaCO2): repeated measures every 90 seconds after induction
data collected from serial arterial blood gas measurements
Measured: 0-9 minutes after induction
Lowest oxygen saturation by pulse oximetry (SpO2) encountered during study
continuous monitoring: data collected from electronic charting software
Measured: 0-9 minutes after induction
Time to desaturation below 95% SpO2
continuous monitoring: data collected from electronic charting software
Measured: 0-9 minutes after induction
Number of participants with SpO2 below 95%
continuous monitoring: data collected from electronic charting software
Measured: 0-9 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2016
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Apneic OxygenationStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Tim Mullen, Nova Scotia Health Authority
- Investigators
- Tim Mullen, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755389
- Sponsor's protocol ID
- CapitalDHACanada
- Status last verified
- Jun 2018
- First submitted
- 25 Apr 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
PubMed 25388828Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
PubMed 20400000Christodoulou C, Rohald P, Mullen T. (2013). Apneic oxygenation via nasal prongs at 10 L/min prevents hypoxemia during tracheal intubation for elective surgery. European Respiratory Society Annual Congress 2013. Abstract Number: 5356 Publication Number: P4923
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apneic Oxygenation Via Nasal Cannulae: 15 L/Min vs High-Flow
- ClinicalTrials.gov ID
- NCT02755389
- Acronym / sponsor ID
- CapitalDHACanada
- Conditions
- Apneic Oxygenation
- Keywords
- Tracheal intubation, High flow nasal oxygen, Airway management, Apneic oxygenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- Sep 2016 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
This is a randomized clinical trial investigating the utility of apneic oxygenation via nasal cannulae in the post-induction setting for the purpose of prolonging the safe apneic time. Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min group. The primary outcome will be the difference in the partial pressure of oxygen in arterial blood (PaO2) between groups throughout the nine-minute apneic period.
Detailed description
Airway management can be a life saving therapy. One major complication that may occur during airway management is a lack of oxygen in the blood. If severe or prolonged, this lack of oxygen can result in permanent brain damage, damage to other vital organs or even death. Strategies already exist to help prevent a lack of oxygen in the blood (hypoxemia), however research involving new ways to oxygenate patients may help to minimize the chance of hypoxemia during airway management. Apneic oxygenation is a novel method of delivering oxygen to a patient despite a lack of active respiration (i.e. the patient is not breathing on their own and the investigators are not providing the patient an artificial breath). The simplest and least invasive method to provide apneic oxygenation is the application of oxygen through nasal cannulae during airway management. Several different techniques to provide apneic oxygenation via nasal cannulae have been previously described(1-3), however randomized trials comparing these methods do not exist. This study will examine the change over time of the amount of oxygen dissolved in the blood (PaO2) in each of the three treatment groups: a control group (no apneic oxygenation), a 15 L/min group and a 60 L/min group. This data will help to determine the extent of benefit apneic oxygenation provides in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0 L/min | Placebo comparator | Drug: 0 L/min oxygen via conventional nasal cannulaeThese participants will receive 0 L/min oxygen via conventional nasal cannulae during the apneic period. |
| 15 L/min | Experimental | Drug: 15 L/min oxygen via conventional nasal cannulaeThese participants will receive 15 L/min oxygen via conventional nasal cannulae during the apneic period. |
| 60 L/min | Experimental | Drug: 60 L/min oxygen via high-flow nasal cannulaeThese participants will receive 60 L/min oxygen via high-flow nasal cannulae during the apneic period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Physical Status Classification 1 to 3
- Body Mass Index 28 to 35
- Elective surgery under general anesthesia
Key exclusion criteria (17 listed)
- Evidence of difficult airway management (from patient history or clinical examination)
- Features suggestive of difficult bag mask ventilation
- Significant uncontrolled gastroesophageal reflux disease
- Significant respiratory disease (including severe asthma or chronic obstructive pulmonary disease, oxygen dependency, pulmonary hypertension, identified by pulmonary function tests or inability to climb one flight of stairs)
- Significant cardiac disease (ischemic heart disease, severe valvular disease, severe arrhythmia, congestive heart failure, ejection fraction < 50%, inability to climb one flight of stairs)
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 |
|---|---|---|
| 0 L/min oxygen via conventional nasal cannulaeAlso: 0 L/min apneic oxygenationPatients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be no oxygen flowing through the cannulae in this group during the study. | Drug | 0 L/min |
| 15 L/min oxygen via conventional nasal cannulaeAlso: 15 L/min apneic oxygenationPatients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 15 L/min of oxygen flowing through the cannulae in this group during the study. | Drug | 15 L/min |
| 60 L/min oxygen via high-flow nasal cannulaeAlso: 60 L/min apneic oxygenationPatients will have high-flow nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 60 L/min of oxygen flowing through the cannulae in this group during the study. | Drug | 60 L/min |
Primary outcome
PaO2: repeated measures every 90 seconds after induction
Time frame: 0-9 minutes after induction
data collected from serial arterial blood gas measurements
4 secondary outcomes
Partial pressure of carbon dioxide in arterial blood (PaCO2): repeated measures every 90 seconds after induction
Time frame: 0-9 minutes after induction
Lowest oxygen saturation by pulse oximetry (SpO2) encountered during study
Time frame: 0-9 minutes after induction
Time to desaturation below 95% SpO2
Time frame: 0-9 minutes after induction
Number of participants with SpO2 below 95%
Time frame: 0-9 minutes after induction
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 27 Jun 2018.
- Background: PubMed 25388828Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
- Background: PubMed 20400000Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
- BackgroundChristodoulou C, Rohald P, Mullen T. (2013). Apneic oxygenation via nasal prongs at 10 L/min prevents hypoxemia during tracheal intubation for elective surgery. European Respiratory Society Annual Congress 2013. Abstract Number: 5356 Publication Number: P4923
- Individual participant dataSharing planned: No
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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.
Tim Mullen, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0 L/min oxygen via conventional nasal cannulae, 15 L/min oxygen via conventional nasal cannulae and 60 L/min oxygen via high-flow nasal cannulae in people with Apneic Oxygenation, run by Nova Scotia Health Authority at 1 site in Canada.
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 17 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 27 Jun 2018. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PaO2: repeated measures every 90 seconds after induction (time frame: 0-9 minutes after induction). 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 NCT02755389, which also lists 3 linked publications.
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 27 Jun 2018.