Clinical trial NCT04926337: Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Hypoxia
Trauma
Rapid Sequence Induction
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All eligable patients suffering Level 1 trauma and in need of emergency anaesthesia will be included.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with a peripheral oxygen saturation (SpO2) below 93%
timeFrame: From start of anaesthesia until 1 minute after tracheal intubation.
Secondary outcomes:
measure: Lowest median SpO2.
timeFrame: From start of anaesthesia until 1 minute after tracheal intubation.
measure: End tidal gas levels
timeFrame: At the first breath after tracheal intubation.
measure: Time span from start of preoxygenation until intubation.
timeFrame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
measure: Time span from entering trauma room until intubation.
timeFrame: Could vary depending on patient and trauma, from a couple of minutes up to an hour.
measure: Difficulties with induction of anaesthesia
timeFrame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
measure: Frequency of complications
timeFrame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
affiliation: Karolinska University Hospital
name: Malin Jonsson Fagerlund
role: PRINCIPAL_INVESTIGATOR
References: