An observational study in Anesthesia, Hypoxia and Trauma, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Karolinska University Hospital · Observational
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 104 is above the median of 67 across 335 observational studies indexed under Hypoxia.
Browse Hypoxia studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All eligable patients suffering Level 1 trauma and in need of emergency anaesthesia will be included.
Exclusion Criteria:
Preoxygenation with tight facemask, 100% oxygen.
Device: Tight Fitting Facemask
Preoxygenation with high flow nasal oxygen, 100% oxygen
Device: High Flow Nasal Oxygen (HFNO)
Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
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.
Time frame: From start of anaesthesia until 1 minute after tracheal intubation.
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
Time frame: 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.
Time frame: 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.
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 span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
Time frame: 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
Time frame: 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.
Time frame: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Plan to share: Undecided
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital