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

Not Applicable

Completed

• Conditions: Surgery; Acute; Anesthesia; Hypoxia
• Interventions: Device: Pre oxygenation using tight fitting facemask; Device: High flow transnasal oxygen

• Registration Number: NCT03516175
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study Start: 2018-03-21
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-28
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tight fitting mask	Pre oxygenation using tight fitting facemask	Pre oxygenation with tight facemask with 100% oxygen
High flow nasal oxygen	High flow transnasal oxygen	High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation

Primary Outcome Measures

Name	Time	Method
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	The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation

Secondary Outcome Measures

Name	Time	Method
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	Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
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	Incidence of gastric regurgitation between the groups?
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	Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
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 carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Difference in numbers of patients being ventilated between the two groups?	From start of anaesthesia until the patient is intubated, usually within 3-4 minutes	Is there a difference in the number of patients that was ventilated before intubation between the two study groups?

Trial Locations

Locations (6)

University Hospital of Bern; 🇨🇭 Bern, Switzerland

St Göran Hospital; 🇸🇪 Stockholm, Sweden

Centralsjukhuset Karlstad; 🇸🇪 Karlstad, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden