Intubation ComplicationPOETNCT03240614
PreOxygenation for EndoTracheal Intubations
A study testing Non-rebreather oxygen mask, Bag-valve-mask and High Flow Nasal Cannulae in people with Intubation Complication and Preoxygenation, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Hypoxemia is a life threatening complication during emergency airway management. Despite advances in technology and training, hypoxemia still occurs in up to a quarter of all intubations placing patients at high risk for damage to vital organs and death. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation Complication, Preoxygenation, Hypoxemia
- What is being tested?
- Non-rebreather oxygen mask, Bag-valve-mask and High Flow Nasal Cannulae
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2018to 15 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a pre-existing arterial line
- Age > 18
- Able to provide consent
Who cannot join
- Acute respiratory distress Defined as RR >30, Baseline oxygen requirements >50%, current use of High Flow Nasal Cannulae or Non-invasive ventilation for respiratory support
- Decreased level of consciousness GCS <13
- Possible exclusion if the allocation to prespecified groups are filled
- Contraindication for high oxygen therapy Severe Chronic Obstructive Pulmonary Disease with documented CO2 retention based on outpatient ABG History of Bleomycin use
- Significant hemodynamic instability Lactate > 3 mmol/L Norepinephrine dose >0.2 mcg/kg/min or equivalent dose of other vasopressors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PreOxygenation for Airway Management: High Flow Versus Conventional Preoxygenation Therapy
Hypoxemia is a life threatening complication during emergency airway management. Despite advances in technology and training, hypoxemia still occurs in up to a quarter of all intubations placing patients at high risk for damage to vital organs and death. A key method in the prevention of hypoxemia is known as preoxygenation which has been shown to decrease the incidence of hypoxemia. Currently there are two conventional methods for preoxygenation in the literature, however recently a new method has been described as a possible alternative method. What is unclear in the literature is if one modality is superior than the other for preoxygenation. The goal of this interventional study is to determine if one method of preoxygenation is superior to the other. This is a 3 arm interventional cross over designed study comparing three interventional methods for preoxygenation. Non-rebreather mask, bag-valve mask and high flow nasal cannulae.
Read the detailed description
In emergency and critical care medicine, one of the most common incidences of severe hypoxemia occurs during the process of endotracheal intubations. Endotracheal intubations, also known as insertion of a breathing tube, is a life saving technique used in medicine to help maintain oxygen delivery, to protect lungs from injury, for patients to safely undergo anesthesia for surgeries, as well as to help rest critically ill patients to allow their bodies time to recover. Despite advances in the field of medicine, the process of placing a breathing tube in emergency situations is still associated with an increase risk of hypoxemia up to 26.7%. This places patients at significant risk for cardiac dysrhythmia, brain damage and hemodynamic decompensation which may ultimately result in death. A UK national review of emergency intubations identified hypoxemia as a cause of death in 50% of intensive care intubations and 27% of Emergency Department intubations. Therefore, it is imperative to improve and develop methods to minimize hypoxemia during airway management.
A vital component used to minimize the risk of hypoxemia during endotracheal intubations is preoxygenation. Preoxygenation is a method to to prolong the time to oxygen desaturation by replacing the lung volume with 100% oxygen compared to 21% oxygen (room air) through the administration of supplemental oxygen. This increases the reservoir of oxygen in the lungs that the body can use to prolong their time to desaturation. Studies have shown a good preoxygenation technique can increase the time to oxygen desaturation from 0.6 min to 8 min in a non obese patient. This remarkable impact at preventing hypoxemia has made preoxygenation the gold standard to minimize hypoxemia during airway management.
Historically preoxygenation with bag-valve-mask ventilation (BVM) and an oxygen non-rebreather mask has been the standard for preoxygenation. Recently, the use of high flow nasal cannulaes have been used for preoxygenation however it is unclear in the literature if one provides a superior preoxygenation compared to another. In an effort to determine the best preoxygenation modality for airway management, the investigators will conduct a 3 arm interventional crossover designed study to compare preoxygenation using a non-rebreather mask, BVM and HFNC in 150 patients. To determine which modality provides the best preoxygenation, arterial blood gases will be taken after each intervention and compared against each other.
Given the high propensity for hypoxemia during airway management in the obese and disease lung population, this protocol will have specific groups based on their BMI (<30, 30-35 and >35) as well as the presence of lung disease based upon their PaO2/FiO2 ratio (< 300 lung disease or >300 no lung disease).
However, due to the pandemic, we had to pause recruitment, a decision was made to do an power analysis with the number of patients we had recruited and a decision was made to collapse the study and report or findings.
- Conditions
- Intubation Complication, Preoxygenation, Hypoxemia
- Being tested
- Non-rebreather oxygen mask, Bag-valve-mask, High Flow Nasal Cannulae
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-rebreather oxygen maskDevice
This intervention will be preoxygenation using a Non-rebreather that will be placed upon the participant for preoxygenation. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After 3 minutes, an ABG will be taken and labeled as Intervention A.
Bag-valve-maskDevice
This intervention will be preoxygenation using a BVM apparatus for preoxygenation for 3 minutes. At the end of 3 minutes an ABG will be obtained.
High Flow Nasal CannulaeDevice
This intervention will be preoxygenation using High Flow Nasal Cannulaes at an FiO2 of 100%. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After the 3 minutes, an ABG will be taken and labeled as Intervention C.
| Study group | Role | What they receive |
|---|---|---|
| BMI <30 no lung disease | Active comparator | Patients with a BMI <30 with no lung disease Receives: Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae |
| BMI <30 with lung disease | Active comparator | Patients with a BMI <30 with lung disease Receives: Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae |
| BMI 30-35 with no lung disease | Active comparator | Patients with a BMI between 30 and 35 with no lung disease Receives: Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae |
| BMI 30-35 with lung disease | Active comparator | Patients with a BMI between 30 and 35 with lung disease Receives: Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae |
| BMI >35 with no lung disease | Active comparator | Patients with a BMI> 35 with no lung disease Receives: Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae |
| BMI >35 with lung disease | Active comparator | Patients with a BMI> 35 with lung disease Receives: Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2
Partial pressure of arterial oxygen
Measured: An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Secondary outcomes (2)
PaCO2
Partial pressure of arterial carbon dioxide
Measured: An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Patient comfort
Numeric scoring of patient comfort for each intervention
Measured: At the conclusion of all interventions the data will be collected on each individual participant. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start30 Jul 2018
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Pandemic and loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Will test preoxygenation using High Flow Nasal Cannulae, Non-rebreather mask and Bag-Valve-Mask
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240614
- Sponsor's protocol ID
- POET1
- Acronym
- POET
- Status last verified
- Mar 2021
- First submitted
- 1 Aug 2017
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gebremedhn EG, Mesele D, Aemero D, Alemu E. The incidence of oxygen desaturation during rapid sequence induction and intubation. World J Emerg Med. 2014;5(4):279-85. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.007.
PubMed 25548602Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
PubMed 21447489Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
PubMed 19399574Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PubMed 22050948
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreOxygenation for Airway Management: High Flow Versus Conventional Preoxygenation Therapy
- ClinicalTrials.gov ID
- NCT03240614
- Acronym / sponsor ID
- POET / POET1
- Conditions
- Intubation Complication, Preoxygenation, Hypoxemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pandemic and loss of funding
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 7 Aug 2017 (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.
Hypoxemia is a life threatening complication during emergency airway management. Despite advances in technology and training, hypoxemia still occurs in up to a quarter of all intubations placing patients at high risk for damage to vital organs and death. A key method in the prevention of hypoxemia is known as preoxygenation which has been shown to decrease the incidence of hypoxemia. Currently there are two conventional methods for preoxygenation in the literature, however recently a new method has been described as a possible alternative method. What is unclear in the literature is if one modality is superior than the other for preoxygenation. The goal of this interventional study is to determine if one method of preoxygenation is superior to the other. This is a 3 arm interventional cross over designed study comparing three interventional methods for preoxygenation. Non-rebreather mask, bag-valve mask and high flow nasal cannulae.
Detailed description
In emergency and critical care medicine, one of the most common incidences of severe hypoxemia occurs during the process of endotracheal intubations. Endotracheal intubations, also known as insertion of a breathing tube, is a life saving technique used in medicine to help maintain oxygen delivery, to protect lungs from injury, for patients to safely undergo anesthesia for surgeries, as well as to help rest critically ill patients to allow their bodies time to recover. Despite advances in the field of medicine, the process of placing a breathing tube in emergency situations is still associated with an increase risk of hypoxemia up to 26.7%. This places patients at significant risk for cardiac dysrhythmia, brain damage and hemodynamic decompensation which may ultimately result in death. A UK national review of emergency intubations identified hypoxemia as a cause of death in 50% of intensive care intubations and 27% of Emergency Department intubations. Therefore, it is imperative to improve and develop methods to minimize hypoxemia during airway management.
A vital component used to minimize the risk of hypoxemia during endotracheal intubations is preoxygenation. Preoxygenation is a method to to prolong the time to oxygen desaturation by replacing the lung volume with 100% oxygen compared to 21% oxygen (room air) through the administration of supplemental oxygen. This increases the reservoir of oxygen in the lungs that the body can use to prolong their time to desaturation. Studies have shown a good preoxygenation technique can increase the time to oxygen desaturation from 0.6 min to 8 min in a non obese patient. This remarkable impact at preventing hypoxemia has made preoxygenation the gold standard to minimize hypoxemia during airway management.
Historically preoxygenation with bag-valve-mask ventilation (BVM) and an oxygen non-rebreather mask has been the standard for preoxygenation. Recently, the use of high flow nasal cannulaes have been used for preoxygenation however it is unclear in the literature if one provides a superior preoxygenation compared to another. In an effort to determine the best preoxygenation modality for airway management, the investigators will conduct a 3 arm interventional crossover designed study to compare preoxygenation using a non-rebreather mask, BVM and HFNC in 150 patients. To determine which modality provides the best preoxygenation, arterial blood gases will be taken after each intervention and compared against each other.
Given the high propensity for hypoxemia during airway management in the obese and disease lung population, this protocol will have specific groups based on their BMI (<30, 30-35 and >35) as well as the presence of lung disease based upon their PaO2/FiO2 ratio (< 300 lung disease or >300 no lung disease).
However, due to the pandemic, we had to pause recruitment, a decision was made to do an power analysis with the number of patients we had recruited and a decision was made to collapse the study and report or findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Will test preoxygenation using High Flow Nasal Cannulae, Non-rebreather mask and Bag-Valve-Mask
| Arm | Type | Receives |
|---|---|---|
| BMI <30 no lung disease | Active comparator | Device: Non-rebreather oxygen mask, Device: Bag-valve-mask, Device: High Flow Nasal CannulaePatients with a BMI <30 with no lung disease |
| BMI <30 with lung disease | Active comparator | Device: Non-rebreather oxygen mask, Device: Bag-valve-mask, Device: High Flow Nasal CannulaePatients with a BMI <30 with lung disease |
| BMI 30-35 with no lung disease | Active comparator | Device: Non-rebreather oxygen mask, Device: Bag-valve-mask, Device: High Flow Nasal CannulaePatients with a BMI between 30 and 35 with no lung disease |
| BMI 30-35 with lung disease | Active comparator | Device: Non-rebreather oxygen mask, Device: Bag-valve-mask, Device: High Flow Nasal CannulaePatients with a BMI between 30 and 35 with lung disease |
| BMI >35 with no lung disease | Active comparator | Device: Non-rebreather oxygen mask, Device: Bag-valve-mask, Device: High Flow Nasal CannulaePatients with a BMI> 35 with no lung disease |
| BMI >35 with lung disease | Active comparator | Device: Non-rebreather oxygen mask, Device: Bag-valve-mask, Device: High Flow Nasal CannulaePatients with a BMI> 35 with lung disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a pre-existing arterial line
- Age > 18
- Able to provide consent
Key exclusion criteria (5 listed)
- Acute respiratory distress Defined as RR >30, Baseline oxygen requirements >50%, current use of High Flow Nasal Cannulae or Non-invasive ventilation for respiratory support
- Decreased level of consciousness GCS <13
- Possible exclusion if the allocation to prespecified groups are filled
- Contraindication for high oxygen therapy Severe Chronic Obstructive Pulmonary Disease with documented CO2 retention based on outpatient ABG History of Bleomycin use
- Significant hemodynamic instability Lactate > 3 mmol/L Norepinephrine dose >0.2 mcg/kg/min or equivalent dose of other vasopressors
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 |
|---|---|---|
| Non-rebreather oxygen maskThis intervention will be preoxygenation using a Non-rebreather that will be placed upon the participant for preoxygenation. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After 3 minutes, an ABG will be taken and labeled as Intervention A. | Device | BMI 30-35 with lung disease, BMI 30-35 with no lung disease, BMI <30 no lung disease, BMI <30 with lung disease, BMI >35 with lung disease, BMI >35 with no lung disease |
| Bag-valve-maskThis intervention will be preoxygenation using a BVM apparatus for preoxygenation for 3 minutes. At the end of 3 minutes an ABG will be obtained. | Device | BMI 30-35 with lung disease, BMI 30-35 with no lung disease, BMI <30 no lung disease, BMI <30 with lung disease, BMI >35 with lung disease, BMI >35 with no lung disease |
| High Flow Nasal CannulaeThis intervention will be preoxygenation using High Flow Nasal Cannulaes at an FiO2 of 100%. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After the 3 minutes, an ABG will be taken and labeled as Intervention C. | Device | BMI 30-35 with lung disease, BMI 30-35 with no lung disease, BMI <30 no lung disease, BMI <30 with lung disease, BMI >35 with lung disease, BMI >35 with no lung disease |
Primary outcome
PaO2
Time frame: An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Partial pressure of arterial oxygen
2 secondary outcomes
PaCO2
Time frame: An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Patient comfort
Time frame: At the conclusion of all interventions the data will be collected on each individual participant. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Results and safety
The study was stopped early (reason given: Pandemic and loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 25548602Gebremedhn EG, Mesele D, Aemero D, Alemu E. The incidence of oxygen desaturation during rapid sequence induction and intubation. World J Emerg Med. 2014;5(4):279-85. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.007.
- Background: PubMed 21447489Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
- Background: PubMed 19399574Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
- Background: PubMed 22050948Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-rebreather oxygen mask, Bag-valve-mask and High Flow Nasal Cannulae in people with Intubation Complication and Preoxygenation, 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 5 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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. 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 was stopped early (reason given: Pandemic and loss of funding). Results are not available in the source record.
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 (time frame: An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.). 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 NCT03240614, which also lists 4 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 5 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.