Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia (PRIOR2)

Karolinska University Hospital

Status: Completed

Conditions: Acute; Surgery; Hypoxia; Anesthesia

Treatments: Device: High flow transnasal oxygen; Device: Pre oxygenation using tight fitting facemask

Study type: Interventional

Funder types: Other

Identifiers

NCT03516175

PRIOR2

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult, >18 years old
2. Emergency intubation where Rapid Sequence Induction is indicated
3. Capable of understanding the study information and signing the written consent.

Exclusion criteria

1. Body Mass Index >35
2. Pregnancy
3. Dependency on non-invasive ventilation to maintain oxygen saturation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Tight fitting mask

Active Comparator group

Description:

Pre oxygenation with tight facemask with 100% oxygen

Treatment:

Device: Pre oxygenation using tight fitting facemask

High flow nasal oxygen

Experimental group

Description:

High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation

Treatment:

Device: High flow transnasal oxygen