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

Surgery Clinical Trial

— PRIOR2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516175
• Other study ID #: PRIOR2
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: October 28, 2020

Study information

• Verified date: December 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 28, 2020
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute
• Anesthesia
• Hypoxia
• Surgery

Intervention

Device:
• High flow transnasal oxygen
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
• Pre oxygenation using tight fitting facemask
100% oxygen via a tight fitting facemask

Locations

Country	Name	City	State
Sweden	Centralsjukhuset Karlstad	Karlstad
Sweden	Linköping University Hospital	Linköping
Sweden	Karolinska University Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm
Sweden	St Göran Hospital	Stockholm
Switzerland	University Hospital of Bern	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Poole Hospital NHS Foundation Trust, St. George's Hospital, London, University College London Hospitals

Countries where clinical trial is conducted

Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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