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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Surgery; Anesthesia; Acute
• Intervention / Treatment: Device: Pre oxygenation using tight fitting facemask; Device: High flow transnasal oxygen

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Karlstad, Sweden
    • Centralsjukhuset Karlstad
  • Linköping, Sweden
    • Linkoping University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital
  • Stockholm, Sweden
    • Sodersjukhuset
  • Stockholm, Sweden
    • St Goran Hospital
• Switzerland
  • Bern, Switzerland
    • University Hospital of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: University College London Hospitals; St. George's Hospital, London; Poole Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): October 28, 2020
• Study Completion (Actual): October 28, 2020

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: PRIOR2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No