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

Primary Purpose

Anesthesia, Hypoxia, Surgery

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High flow transnasal oxygen
Pre oxygenation using tight fitting facemask
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centralsjukhuset Karlstad
  • Linköping University Hospital
  • Karolinska University Hospital
  • St Göran Hospital
  • Södersjukhuset
  • University Hospital of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tight fitting mask

High flow nasal oxygen

Arm Description

Pre oxygenation with tight facemask with 100% oxygen

High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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?
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?
Incidence of gastric regurgitation between the groups?
Incidence of gastric regurgitation between the groups?
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?

Full Information

First Posted
March 20, 2018
Last Updated
December 9, 2020
Sponsor
Karolinska University Hospital
Collaborators
St. George's Hospital, London, University College London Hospitals, Poole Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03516175
Brief Title
Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
October 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
St. George's Hospital, London, University College London Hospitals, Poole Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Hypoxia, Surgery, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tight fitting mask
Arm Type
Active Comparator
Arm Description
Pre oxygenation with tight facemask with 100% oxygen
Arm Title
High flow nasal oxygen
Arm Type
Experimental
Arm Description
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation
Intervention Type
Device
Intervention Name(s)
High flow transnasal oxygen
Other Intervention Name(s)
Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Intervention Description
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Intervention Type
Device
Intervention Name(s)
Pre oxygenation using tight fitting facemask
Intervention Description
100% oxygen via a tight fitting facemask
Primary Outcome Measure Information:
Title
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
Description
The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
Time Frame
From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Secondary Outcome Measure Information:
Title
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Description
Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
Time Frame
From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Title
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?
Description
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?
Time Frame
At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Title
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Description
Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
Time Frame
At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
Title
Incidence of gastric regurgitation between the groups?
Description
Incidence of gastric regurgitation between the groups?
Time Frame
From start of anaesthesia until 2 minutes after tracheal intubation, that is normally after 4-5 minutes after anaesthesia induction
Title
Difference in numbers of patients being ventilated between the two groups?
Description
Is there a difference in the number of patients that was ventilated before intubation between the two study groups?
Time Frame
From start of anaesthesia until the patient is intubated, usually within 3-4 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jonsson Fagerlund
Organizational Affiliation
Karolinska University Hospital and Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centralsjukhuset Karlstad
City
Karlstad
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
St Göran Hospital
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
University Hospital of Bern
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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