AnesthesiaNCT05839665
Evaluation of Different Methods for Preoxygenation
A study testing Humidified high-flow nasal oxygen, Standard nasal cannula and Facemask in people with Anesthesia, run by Malin Jonsson Fagerlund at 2 sites in Sweden.
Trial summary
The goal of this randomised cross-over study is to compare pre-oxygenation using a standard nasal cannula to pre-oxygenation using humidified high-flow nasal oxygen and a tight-fitting facemask in adult volunteers with a BMI below 30 not suffering from pulmonary or cardiac comorbidity. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Humidified high-flow nasal oxygen, Standard nasal cannula and Facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSweden
- Study dates
- 2 May 2023to 31 May 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and sign informed consent
- Age 25-65 years
- Body mass index <30
Who cannot join
- Heart disease
- Respiratory disease
- Pregnancy
- Smoker
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Perioperative Medicine and Intensive Care Medicine
Stockholm, SE-17176
Karolinska University Hospital, Solna
Stockholm
About this study
The goal of this randomised cross-over study is to compare pre-oxygenation using a standard nasal cannula to pre-oxygenation using humidified high-flow nasal oxygen and a tight-fitting facemask in adult volunteers with a BMI below 30 not suffering from pulmonary or cardiac comorbidity.
The main question it aims to answer is:
Read more
- Are there any differences in the effectiveness of pre-oxygenation using a standard nasal cannula compared to using a traditional facemask and pre-oxygenation using humidified high-flow nasal oxygen?
Participants will be pre-oxygenated with 100% oxygen during four minutes intervals. All participants will be pre-oxygenated with various flow rates using a standard nasal cannula, a facemask and humidified high-flow nasal oxygen. End-tidal oxygen concentrations will be measured continuously in order to evaluate the effectiveness of pre-oxygenation.
Each volunteer will be pre-oxygenated repeatedly, with different flow rates, with all three methods of pre-oxygenation and act as its own control.
During facemask pre-oxygenation volunteers will be pre-oxygenated using both tidal volume breathing for four minutes and with eight vital capacity breaths. During pre-oxygenation using the standard nasal cannula flow rates will vary between 15 and 50 l/min. Pre-oxygenation using humidified high-flow nasal oxygen will be performed with flow rates varying between 30 and 50 l/min. Series will be conducted with volunteers breathing with both opened and closed mouth as well as with four minutes of tidal volume breathing and eight vital capacity breaths.
All volunteers will start with facemask pre-oxygenation. They will thereafter be randomised to pre-oxygenation with either a standard nasal cannula or humidified high-flow nasal oxygen. Lastly, they will be pre-oxygenated with the remaining method according to the randomisation.
Read the detailed description
Pre-oxygenation before anaesthesia induction is mostly performed using a tight-fitting facemask. Recently, studies have shown that pre-oxygenation using humidified high-flow nasal oxygen is equally effective as pre-oxygenation using a standard tight-fitting facemask. Pre-oxygenation using humidified high-flow nasal oxygen has several potential advantages including improved patient comfort and the possibility of a seamless transition from pre-oxygenation to apnoeic oxygenation. Unfortunately, this technique requires an additional machine which can be expensive and also difficult to use in settings outside a hospital.
In this study, pre-oxygenation using a standard nasal cannula delivering a high flow of oxygen will be compared with standard facemask pre-oxygenation and pre-oxygenation using humidified high-flow nasal oxygen in adult volunteers with a BMI below 30 not suffering from pulmonary or cardiac comorbidity.
The main question it aims to answer is:
- Are there any differences in the effectiveness of pre-oxygenation using a standard nasal cannula compared to using a traditional facemask and pre-oxygenation using humidified high-flow nasal oxygen?
Participants will be pre-oxygenated with 100% oxygen during four minutes intervals. All participants will be pre-oxygenated with various flow rates using a standard nasal cannula, a facemask and humidified high-flow nasal oxygen. End-tidal oxygen concentrations will be measured continuously in order to evaluate the effectiveness of pre-oxygenation.
Each volunteer will be pre-oxygenated repeatedly, with different flow rates, with all three methods of pre-oxygenation and act as its own control.
During facemask pre-oxygenation volunteers will be pre-oxygenated using both tidal volume breathing for four minutes and with eight vital capacity breaths. During pre-oxygenation using the standard nasal cannula flow rates will vary between 15 and 50 l/min. Pre-oxygenation using humidified high-flow nasal oxygen will be performed with flow rates varying between 30 and 50 l/min. Series will be conducted with volunteers breathing with both opened and closed mouth as well as with four minutes of tidal volume breathing and eight vital capacity breaths.
All volunteers will start with facemask pre-oxygenation. They will thereafter be randomised to pre-oxygenation with either a standard nasal cannula or humidified high-flow nasal oxygen. Lastly, they will be pre-oxygenated with the remaining method according to the randomisation.
- Conditions
- Anesthesia
- Being tested
- Humidified high-flow nasal oxygen, Standard nasal cannula, Facemask
- Keywords
- Preoxygenation, Oxygenation, High-flow nasal oxygen, Low-flow nasal oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidified high-flow nasal oxygenDevice
Humidified high-flow oxygen delivered via the Optiflow device
Standard nasal cannulaDevice
Oxygen delivered with high flows via a standard nasal cannula
FacemaskDevice
Oxygen delivered with facemask
| Study group | Role | What they receive |
|---|---|---|
| Humidified high-flow oxygen | Active comparator | Humidified high-flow nasal oxygen delivered via the Optiflow device. Repeated series with 100% oxygen with flows varying between 30 to 50 l/min. Volunteers will also be pre-oxygenated with both opened and closed mouth. Receives: Device: Humidified high-flow nasal oxygen |
| Standard nasal cannula | Experimental | Standard nasal cannula connected to an oxygen rotameter Repeated series with 100% oxygen with flows varying between 15 to 50 l/min. Volunteers will also be pre-oxygenated with both opened and closed mouth. Receives: Device: Standard nasal cannula |
| Facemask | Active comparator | Tight-fitting facemask. Two series will be done where pre-oxygenation will be performed with four minutes of tidal volume breathing and eight vital capacity breaths.
This arm is not randomised. All study subjects will start with facemask pre-oxygenation and are thereafter randomised to standard nasal cannula or humidified high-flow nasal cannula. Receives: Device: Facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effectiveness of pre-oxygenation
Compare end-tidal oxygen levels after three minutes of pre-oxygenation using a standard facemask, high-flow nasal oxygen and a standard nasal cannula.
Measured: After 3 minutes of preoxygenation
Secondary outcomes (7)
Duration of pre-oxygenation until end-tidal oxygen levels above 80%
Evaluation of end-tidal oxygen levels will be done each minute during all series of pre-oxygenation in order to investigate the time taken until reaching end-tidal levels above 80%. A comparison between the time taken to achieve end-tidal levels above 80% will be done between the different methods of pre-oxygenation as well as the different flow rates.
Measured: After 3 minutes of preoxygenation
Duration of pre-oxygenation until end-tidal oxygen levels above 85%
Evaluation of end-tidal oxygen levels will be done each minute during all series of pre-oxygenation in order to investigate the time taken until reaching end-tidal levels above 85%. A comparison between the time taken to achieve end-tidal levels above 80% will be done between the different methods of pre-oxygenation as well as the different flow rates.
Measured: After 3 minutes of preoxygenation
Continuous comparison of end-tidal oxygen levels
Evaluation of end-tidal oxygen levels will be done after one, two, three and four minutes of pre-oxygenation. Comparison between the different methods and flow rates of pre-oxygenation will be done in order to evaluate which method and flow rate generates adequate end-tidal oxygen levels most quickly.
Measured: After 3 minutes of preoxygenation
Pre-oxygenation with open and closed mouth
All volunteers will be pre-oxygenated with both open and closed mouths in order to evaluate if there are any differences in end-tidal oxygen levels when breathing with open or closed mouth.
Measured: After 3 minutes of preoxygenation
Vital capacity breathing vs tidal volume breathing
End-tidal oxygen levels during pre-oxygenation will be evaluated and compared between tidal volume breathing for three minutes and eight vital capacity breaths.
Measured: After 3 minutes of preoxygenation
Differences in end-tidal oxygen levels after pre-oxygenation due to age, body mass index or sex.
Subgroup analysis will be performed in order to investigate any differences in the effect of pre-oxygenation depending on volunteer age, body mass index or sex.
Measured: After 3 minutes of preoxygenation
Discomfort
Level of discomfort, on a scale between one and ten, where ten is the worst discomfort and 0 is the best comfort) will be compared between the three different methods of pre-oxygenation and the different flow rates.
Measured: After 3 minutes of preoxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 May 2023
- Primary completion31 May 2023
- Study completion31 May 2023
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 AnesthesiaStudies 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
- Crossover
- Model description
- All volunteers will start with pre-oxygenation using a traditional facemask (vital breathing for four minutes vital and eight vital capacity breaths). They will thereafter be randomised to continue with either pre-oxygenation using a standard nasal cannula or humidified high-flow nasal oxygen.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malin Jonsson Fagerlund
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor-investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839665
- Sponsor's protocol ID
- PreFlow
- Status last verified
- Aug 2023
- First submitted
- 20 Apr 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sjoblom A, Hedberg M, Forsberg IM, Hoffman F, Jonsson Fagerlund M. Comparison of preoxygenation using a tight facemask, humidified high-flow nasal oxygen and a standard nasal cannula - a volunteer, randomised, crossover study. Eur J Anaesthesiol. 2024 Jun 1;41(6):430-437. doi: 10.1097/EJA.0000000000001989. Epub 2024 Apr 16.
PubMed 38630525
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Methods for Preoxygenation
- ClinicalTrials.gov ID
- NCT05839665
- Acronym / sponsor ID
- PreFlow
- Conditions
- Anesthesia
- Keywords
- Preoxygenation, Oxygenation, High-flow nasal oxygen, Low-flow nasal oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Malin Jonsson FagerlundUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 3 May 2023 (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.
The goal of this randomised cross-over study is to compare pre-oxygenation using a standard nasal cannula to pre-oxygenation using humidified high-flow nasal oxygen and a tight-fitting facemask in adult volunteers with a BMI below 30 not suffering from pulmonary or cardiac comorbidity.
The main question it aims to answer is:
- Are there any differences in the effectiveness of pre-oxygenation using a standard nasal cannula compared to using a traditional facemask and pre-oxygenation using humidified high-flow nasal oxygen?
Participants will be pre-oxygenated with 100% oxygen during four minutes intervals. All participants will be pre-oxygenated with various flow rates using a standard nasal cannula, a facemask and humidified high-flow nasal oxygen. End-tidal oxygen concentrations will be measured continuously in order to evaluate the effectiveness of pre-oxygenation.
Each volunteer will be pre-oxygenated repeatedly, with different flow rates, with all three methods of pre-oxygenation and act as its own control.
During facemask pre-oxygenation volunteers will be pre-oxygenated using both tidal volume breathing for four minutes and with eight vital capacity breaths. During pre-oxygenation using the standard nasal cannula flow rates will vary between 15 and 50 l/min. Pre-oxygenation using humidified high-flow nasal oxygen will be performed with flow rates varying between 30 and 50 l/min. Series will be conducted with volunteers breathing with both opened and closed mouth as well as with four minutes of tidal volume breathing and eight vital capacity breaths.
All volunteers will start with facemask pre-oxygenation. They will thereafter be randomised to pre-oxygenation with either a standard nasal cannula or humidified high-flow nasal oxygen. Lastly, they will be pre-oxygenated with the remaining method according to the randomisation.
Detailed description
Pre-oxygenation before anaesthesia induction is mostly performed using a tight-fitting facemask. Recently, studies have shown that pre-oxygenation using humidified high-flow nasal oxygen is equally effective as pre-oxygenation using a standard tight-fitting facemask. Pre-oxygenation using humidified high-flow nasal oxygen has several potential advantages including improved patient comfort and the possibility of a seamless transition from pre-oxygenation to apnoeic oxygenation. Unfortunately, this technique requires an additional machine which can be expensive and also difficult to use in settings outside a hospital.
In this study, pre-oxygenation using a standard nasal cannula delivering a high flow of oxygen will be compared with standard facemask pre-oxygenation and pre-oxygenation using humidified high-flow nasal oxygen in adult volunteers with a BMI below 30 not suffering from pulmonary or cardiac comorbidity.
The main question it aims to answer is:
- Are there any differences in the effectiveness of pre-oxygenation using a standard nasal cannula compared to using a traditional facemask and pre-oxygenation using humidified high-flow nasal oxygen?
Participants will be pre-oxygenated with 100% oxygen during four minutes intervals. All participants will be pre-oxygenated with various flow rates using a standard nasal cannula, a facemask and humidified high-flow nasal oxygen. End-tidal oxygen concentrations will be measured continuously in order to evaluate the effectiveness of pre-oxygenation.
Each volunteer will be pre-oxygenated repeatedly, with different flow rates, with all three methods of pre-oxygenation and act as its own control.
During facemask pre-oxygenation volunteers will be pre-oxygenated using both tidal volume breathing for four minutes and with eight vital capacity breaths. During pre-oxygenation using the standard nasal cannula flow rates will vary between 15 and 50 l/min. Pre-oxygenation using humidified high-flow nasal oxygen will be performed with flow rates varying between 30 and 50 l/min. Series will be conducted with volunteers breathing with both opened and closed mouth as well as with four minutes of tidal volume breathing and eight vital capacity breaths.
All volunteers will start with facemask pre-oxygenation. They will thereafter be randomised to pre-oxygenation with either a standard nasal cannula or humidified high-flow nasal oxygen. Lastly, they will be pre-oxygenated with the remaining method according to the randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All volunteers will start with pre-oxygenation using a traditional facemask (vital breathing for four minutes vital and eight vital capacity breaths). They will thereafter be randomised to continue with either pre-oxygenation using a standard nasal cannula or humidified high-flow nasal oxygen.
| Arm | Type | Receives |
|---|---|---|
| Humidified high-flow oxygen | Active comparator | Device: Humidified high-flow nasal oxygenHumidified high-flow nasal oxygen delivered via the Optiflow device. Repeated series with 100% oxygen with flows varying between 30 to 50 l/min. Volunteers will also be pre-oxygenated with both opened and closed mouth. |
| Standard nasal cannula | Experimental | Device: Standard nasal cannulaStandard nasal cannula connected to an oxygen rotameter Repeated series with 100% oxygen with flows varying between 15 to 50 l/min. Volunteers will also be pre-oxygenated with both opened and closed mouth. |
| Facemask | Active comparator | Device: FacemaskTight-fitting facemask. Two series will be done where pre-oxygenation will be performed with four minutes of tidal volume breathing and eight vital capacity breaths. This arm is not randomised. All study subjects will start with facemask pre-oxygenation and are thereafter randomised to standard nasal cannula or humidified high-flow nasal cannula. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to understand and sign informed consent
- Age 25-65 years
- Body mass index <30
Key exclusion criteria (4 listed)
- Heart disease
- Respiratory disease
- Pregnancy
- Smoker
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 |
|---|---|---|
| Humidified high-flow nasal oxygenHumidified high-flow oxygen delivered via the Optiflow device | Device | Humidified high-flow oxygen |
| Standard nasal cannulaOxygen delivered with high flows via a standard nasal cannula | Device | Standard nasal cannula |
| FacemaskOxygen delivered with facemask | Device | Facemask |
Primary outcome
Comparison of the effectiveness of pre-oxygenation
Time frame: After 3 minutes of preoxygenation
Compare end-tidal oxygen levels after three minutes of pre-oxygenation using a standard facemask, high-flow nasal oxygen and a standard nasal cannula.
7 secondary outcomes
Duration of pre-oxygenation until end-tidal oxygen levels above 80%
Time frame: After 3 minutes of preoxygenation
Duration of pre-oxygenation until end-tidal oxygen levels above 85%
Time frame: After 3 minutes of preoxygenation
Continuous comparison of end-tidal oxygen levels
Time frame: After 3 minutes of preoxygenation
Pre-oxygenation with open and closed mouth
Time frame: After 3 minutes of preoxygenation
Vital capacity breathing vs tidal volume breathing
Time frame: After 3 minutes of preoxygenation
Differences in end-tidal oxygen levels after pre-oxygenation due to age, body mass index or sex.
Time frame: After 3 minutes of preoxygenation
Discomfort
Time frame: After 3 minutes of preoxygenation
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 8 Aug 2023.
- Derived from this study: PubMed 38630525Sjoblom A, Hedberg M, Forsberg IM, Hoffman F, Jonsson Fagerlund M. Comparison of preoxygenation using a tight facemask, humidified high-flow nasal oxygen and a standard nasal cannula - a volunteer, randomised, crossover study. Eur J Anaesthesiol. 2024 Jun 1;41(6):430-437. doi: 10.1097/EJA.0000000000001989. Epub 2024 Apr 16.
- 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.
Malin Jonsson Fagerlund principal investigator
Karolinska University Hospital and Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidified high-flow nasal oxygen, Standard nasal cannula and Facemask in people with Anesthesia, run by Malin Jonsson Fagerlund at 2 sites in Sweden.
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 4 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Comparison of the effectiveness of pre-oxygenation (time frame: After 3 minutes of preoxygenation). 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 NCT05839665, 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 8 Aug 2023.