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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Anesthesia, Hypoxia, Surgery, Acute

Intervention / Treatment
-----------------
* Device: High flow transnasal oxygen
* Device: Pre oxygenation using tight fitting facemask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, >18 years old Emergency intubation where Rapid Sequence Induction is indicated Capable of understanding the study information and signing the written consent. Exclusion Criteria: Body Mass Index >35 Pregnancy Dependency on non-invasive ventilation to maintain oxygen saturation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tight fitting mask<br>Pre oxygenation with tight facemask with 100% oxygen | Device: Pre oxygenation using tight fitting facemask<br>* 100% oxygen via a tight fitting facemask<br>|
| Experimental: High flow nasal oxygen<br>High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation | Device: High flow transnasal oxygen<br>* High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange<br>* Other names: Transnasal Humidified Rapid Insufflation Ventilatory Exchange;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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? | 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? | 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? | 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? | From start of anaesthesia until the patient is intubated, usually within 3-4 minutes |