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NCT Number: NCT04926337

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital Solna

Stockholm, SE-17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tight Fitting Facemask

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lowest median SpO2.

    Time frame: 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

  2. End tidal gas levels

    Time frame: At 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.

  3. 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.

    Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.

  4. 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.

    Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.

  5. Difficulties with induction of anaesthesia

    Time frame: Could 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

  6. Frequency of complications

    Time frame: Could 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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study 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

Acronym: PRIOR-Trauma

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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