ClinicalTrials.Veeva

Menu

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

K

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

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)

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

Trial contacts and locations

6

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems