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Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04926337
Acronym
PRIOR-Trauma
Enrollment
104
Registered
2021-06-15
Start date
2021-06-01
Completion date
2022-12-05
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hypoxia, Rapid Sequence Induction, Trauma

Brief 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. 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.

Interventions

DEVICETight Fitting Facemask

Preoxygenation with tight facemask, 10 L/min, 100% oxygen.

Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with a peripheral oxygen saturation (SpO2) below 93%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.

Secondary

MeasureTime frameDescription
End tidal gas levelsAt the first breath after tracheal intubation.Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
Time span from start of preoxygenation until intubation.Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
Lowest median SpO2.From start of anaesthesia until 1 minute after tracheal intubation.Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
Difficulties with induction of anaesthesiaCould vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
Frequency of complicationsCould vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.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.
Time span from entering trauma room until intubation.Could vary depending on patient and trauma, from a couple of minutes up to an hour.Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026