An interventional study of High flow transnasal oxygen and Pre oxygenation using tight fitting facemask in Anesthesia, Hypoxia and Surgery, sponsored by Karolinska University Hospital. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment
It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. Data from a recent study indicates that Transnasal Humidified Rapid Insufflation Ventilatory Exchange might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The limitations with our previous study is that it was done only during office hours (Mon-Friday 8 am to 4 pm) and that the power to detect the occurrence of desaturation was too low.
Based on the above, the aim is now to conduct a clinical international multicenter study 24/7 with 450 patients and with a simplified protocol that allows the study to be done 24/7. This study is done with the aim of evaluation before implementing this novel technique of preoxygenation into clinical practice.
The general purpose of this project is to compare a the preoxygenation technique based on Transnasal Humidified Rapid Insufflation Ventilatory Exchange with traditional preoxygenation with a tight fitting mask during rapid sequence induction (RSI) intubation in patients undergoing emergency surgery.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 350 is above the median of 45 across 853 interventional 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.
Exclusion Criteria:
Pre oxygenation with tight facemask with 100% oxygen
Device: Pre oxygenation using tight fitting facemask
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation
Device: High flow transnasal oxygen
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Also known as: Transnasal Humidified Rapid Insufflation Ventilatory Exchange
100% oxygen via a tight fitting facemask
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
Time frame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Time frame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Time frame: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Time frame: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Incidence of gastric regurgitation between the groups?
Incidence of gastric regurgitation between the groups?
Time frame: From start of anaesthesia until 2 minutes after tracheal intubation, that is normally after 4-5 minutes after anaesthesia induction
Difference in numbers of patients being ventilated between the two groups?
Is there a difference in the number of patients that was ventilated before intubation between the two study groups?
Time frame: From start of anaesthesia until the patient is intubated, usually within 3-4 minutes
Plan to share: Undecided
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital