NCT03516175

Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia

Pre-oxygenation With High-flow Nasal Cannula in Comparison to Standard in Adults During Rapid Sequence Induction Anesthesia- a Prospective Randomized Non-blinded International Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anesthesia
• Hypoxia
• Surgery
• Acute

Interventions

Type	Name	Description
DEVICE	High flow transnasal oxygen	High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
DEVICE	Pre oxygenation using tight fitting facemask	100% oxygen via a tight fitting facemask

Timeline

• Start date: 2018-03-21
• Primary completion: 2020-10-28
• Completion: 2020-10-28
• First posted: 2018-05-04
• Last updated: 2020-12-10

Locations

6 sites across 2 countries: Sweden, Switzerland