AnesthesiaPRIOR2NCT03516175
Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia
A study testing High flow transnasal oxygen and Pre oxygenation using tight fitting facemask in people with Anesthesia and Hypoxia, run by Karolinska University Hospital at 6 sites in 2 countries.
Trial summary
It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Hypoxia, Surgery
- What is being tested?
- High flow transnasal oxygen and Pre oxygenation using tight fitting facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Mar 2018to 28 Oct 2020
- 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
- Adult, >18 years old
- Emergency intubation where Rapid Sequence Induction is indicated
- Capable of understanding the study information and signing the written consent.
Who cannot join
- Body Mass Index >35
- Pregnancy
- Dependency on non-invasive ventilation to maintain oxygen saturation
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Sweden5 sites
Centralsjukhuset Karlstad
Karlstad
Linköping University Hospital
Linköping
Karolinska University Hospital
Stockholm
St Göran Hospital
Stockholm
Södersjukhuset
Stockholm
About this study
Official title: Pre-oxygenation With High-flow Nasal Cannula in Comparison to Standard in Adults During Rapid Sequence Induction Anesthesia- a Prospective Randomized Non-blinded International Multicenter Study
It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. Data from a recent study indicates that Transnasal Humidified Rapid Insufflation Ventilatory Exchange might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The limitations with our previous study is that it was done only during office hours (Mon-Friday 8 am to 4 pm) and that the power to detect the occurrence of desaturation was too low.
Based on the above, the aim is now to conduct a clinical international multicenter study 24/7 with 450 patients and with a simplified protocol that allows the study to be done 24/7. This study is done with the aim of evaluation before implementing this novel technique of preoxygenation into clinical practice.
The general purpose of this project is to compare a the preoxygenation technique based on Transnasal Humidified Rapid Insufflation Ventilatory Exchange with traditional preoxygenation with a tight fitting mask during rapid sequence induction (RSI) intubation in patients undergoing emergency surgery.
- Conditions
- Anesthesia, Hypoxia, Surgery, Acute
- Being tested
- High flow transnasal oxygen, Pre oxygenation using tight fitting facemask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow transnasal oxygenDevice
Also called Transnasal Humidified Rapid Insufflation Ventilatory Exchange
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Pre oxygenation using tight fitting facemaskDevice
100% oxygen via a tight fitting facemask
| Study group | Role | What they receive |
|---|---|---|
| Tight fitting mask | Active comparator | Pre oxygenation with tight facemask with 100% oxygen Receives: Device: Pre oxygenation using tight fitting facemask |
| High flow nasal oxygen | Experimental | High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation Receives: Device: High flow transnasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
Measured: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Secondary outcomes (5)
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Measured: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Measured: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Measured: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Incidence of gastric regurgitation between the groups?
Incidence of gastric regurgitation between the groups?
Measured: From start of anaesthesia until 2 minutes after tracheal intubation, that is normally after 4-5 minutes after anaesthesia induction
Difference in numbers of patients being ventilated between the two groups?
Is there a difference in the number of patients that was ventilated before intubation between the two study groups?
Measured: From start of anaesthesia until the patient is intubated, usually within 3-4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start21 Mar 2018
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. George's Hospital, London, University College London Hospitals, Poole Hospital NHS Foundation Trust
- Responsible party
- Principal 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
- NCT03516175
- Sponsor's protocol ID
- PRIOR2
- Acronym
- PRIOR2
- Status last verified
- Dec 2020
- First submitted
- 20 Mar 2018
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-oxygenation With High-flow Nasal Cannula in Comparison to Standard in Adults During Rapid Sequence Induction Anesthesia- a Prospective Randomized Non-blinded International Multicenter Study
- ClinicalTrials.gov ID
- NCT03516175
- Acronym / sponsor ID
- PRIOR2 / PRIOR2
- Conditions
- Anesthesia, Hypoxia, Surgery, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- St. George's Hospital, London, University College London Hospitals, Poole Hospital NHS Foundation Trust
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 4 May 2018 (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.
It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. Data from a recent study indicates that Transnasal Humidified Rapid Insufflation Ventilatory Exchange might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The limitations with our previous study is that it was done only during office hours (Mon-Friday 8 am to 4 pm) and that the power to detect the occurrence of desaturation was too low.
Based on the above, the aim is now to conduct a clinical international multicenter study 24/7 with 450 patients and with a simplified protocol that allows the study to be done 24/7. This study is done with the aim of evaluation before implementing this novel technique of preoxygenation into clinical practice.
The general purpose of this project is to compare a the preoxygenation technique based on Transnasal Humidified Rapid Insufflation Ventilatory Exchange with traditional preoxygenation with a tight fitting mask during rapid sequence induction (RSI) intubation in patients undergoing emergency surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight fitting mask | Active comparator | Device: Pre oxygenation using tight fitting facemaskPre oxygenation with tight facemask with 100% oxygen |
| High flow nasal oxygen | Experimental | Device: High flow transnasal oxygenHigh flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult, >18 years old
- Emergency intubation where Rapid Sequence Induction is indicated
- Capable of understanding the study information and signing the written consent.
Key exclusion criteria (3 listed)
- Body Mass Index >35
- Pregnancy
- Dependency on non-invasive ventilation to maintain oxygen saturation
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 |
|---|---|---|
| High flow transnasal oxygenAlso: Transnasal Humidified Rapid Insufflation Ventilatory ExchangeHigh flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange | Device | High flow nasal oxygen |
| Pre oxygenation using tight fitting facemask100% oxygen via a tight fitting facemask | Device | Tight fitting mask |
Primary outcome
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
Time frame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
5 secondary outcomes
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Time frame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Time frame: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Time frame: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Incidence of gastric regurgitation between the groups?
Time frame: From start of anaesthesia until 2 minutes after tracheal intubation, that is normally after 4-5 minutes after anaesthesia induction
Difference in numbers of patients being ventilated between the two groups?
Time frame: From start of anaesthesia until the patient is intubated, usually within 3-4 minutes
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 10 Dec 2020.
- 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.
Malin Jonsson Fagerlund principal investigator
Karolinska University Hospital and Karolinska Institutet
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow transnasal oxygen and Pre oxygenation using tight fitting facemask in people with Anesthesia and Hypoxia, run by Karolinska University Hospital at 6 sites in 2 countries.
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 3 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Switzerland. 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?
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation (time frame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction). 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 10 Dec 2020.