AnesthesiaPRIOR-TraumaNCT04926337
Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia
An observational study of Anesthesia and Hypoxia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Hypoxia, Trauma
- What is being tested?
- Tight Fitting Facemask and High Flow Nasal Oxygen (HFNO)
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2021to 5 Dec 2022
- Phase
- Observational
- 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
Study population: All eligable patients suffering Level 1 trauma and in need of emergency anaesthesia will be included.
Who may be able to join
- 1 Adult, ≥18 years old
- 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).
Who cannot join
- 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.
It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.
Read more
Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.
Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.
The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.
- Conditions
- Anesthesia, Hypoxia, Trauma, Rapid Sequence Induction
- Being tested
- Tight Fitting Facemask, High Flow Nasal Oxygen (HFNO)
- Medical subject headings
- Hypoxia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tight Fitting FacemaskDevice
Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
High Flow Nasal Oxygen (HFNO)Device
Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
| Study group | Role | What they receive |
|---|---|---|
| Tight fitting facemask | Preoxygenation with tight facemask, 100% oxygen. Receives: Device: Tight Fitting Facemask | |
| High flow nasal oxygen | Preoxygenation with high flow nasal oxygen, 100% oxygen Receives: Device: High Flow Nasal Oxygen (HFNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a peripheral oxygen saturation (SpO2) below 93%
Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
Measured: From start of anaesthesia until 1 minute after tracheal intubation.
Secondary outcomes (6)
Lowest median SpO2.
Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
Measured: From start of anaesthesia until 1 minute after tracheal intubation.
End tidal gas levels
Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
Measured: At the first breath after tracheal intubation.
Time span from start of preoxygenation until intubation.
Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
Measured: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Time span from entering trauma room until intubation.
Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
Measured: Could vary depending on patient and trauma, from a couple of minutes up to an hour.
Difficulties with induction of anaesthesia
Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
Measured: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Frequency of complications
Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.
Measured: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jun 2021
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926337
- Sponsor's protocol ID
- PRIOR-Trauma
- Acronym
- PRIOR-Trauma
- Status last verified
- Mar 2023
- First submitted
- 7 Jun 2021
- Last updated
- 8 Mar 2023
- 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 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study
- ClinicalTrials.gov ID
- NCT04926337
- Acronym / sponsor ID
- PRIOR-Trauma / PRIOR-Trauma
- Conditions
- Anesthesia, Hypoxia, Trauma, Rapid Sequence Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 15 Jun 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.
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.
It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.
Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.
Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.
The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight fitting facemask | – | Device: Tight Fitting FacemaskPreoxygenation with tight facemask, 100% oxygen. |
| High flow nasal oxygen | – | Device: High Flow Nasal Oxygen (HFNO)Preoxygenation with high flow nasal oxygen, 100% oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligable patients suffering Level 1 trauma and in need of emergency anaesthesia will be included.
Key inclusion criteria (2 listed)
- 1 Adult, ≥18 years old
- 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).
Key exclusion criteria (1 listed)
- 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
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 |
|---|---|---|
| Tight Fitting FacemaskPreoxygenation with tight facemask, 10 L/min, 100% oxygen. | Device | Tight fitting facemask |
| High Flow Nasal Oxygen (HFNO)Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen. | Device | High flow nasal oxygen |
Primary outcome
Number of patients with a peripheral oxygen saturation (SpO2) below 93%
Time frame: From start of anaesthesia until 1 minute after tracheal intubation.
Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
6 secondary outcomes
Lowest median SpO2.
Time frame: From start of anaesthesia until 1 minute after tracheal intubation.
End tidal gas levels
Time frame: At the first breath after tracheal intubation.
Time span from start of preoxygenation until intubation.
Time frame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Time span from entering trauma room until intubation.
Time frame: Could vary depending on patient and trauma, from a couple of minutes up to an hour.
Difficulties with induction of anaesthesia
Time frame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Frequency of complications
Time frame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 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 8 Mar 2023.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Hypoxia, run by Karolinska University Hospital at 1 site 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 2 inclusion and 1 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 Mar 2023. 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 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?
Number of patients with a peripheral oxygen saturation (SpO2) below 93% (time frame: From start of anaesthesia until 1 minute after tracheal intubation.). 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 8 Mar 2023.