Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia (PRIOR-Trauma)

Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study

Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.

It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.

Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.

Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.

The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Trauma; Anesthesia; Rapid Sequence Induction
• Intervention / Treatment: Device: Tight Fitting Facemask; Device: High Flow Nasal Oxygen (HFNO)

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Malin Jonsson Fagerlund; Phone Number: 0707691405; Email: malin.jonsson-fagerlund@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, SE-17176
    • Recruiting
    • Karolinska University Hospital Solna
    • Contact: Malin Jonsson Fagerlund; Phone Number: +46707691405; Email: malin.jonsson.fagerlund@ki.se

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All eligable patients suffering Level 1 trauma and in need of emergency anaesthesia will be included.

Description

Inclusion Criteria:

• 1 Adult, ≥18 years old
• 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).

Exclusion Criteria:

• 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tight fitting facemask; Preoxygenation with tight facemask, 100% oxygen.	Device: Tight Fitting Facemask; Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
High flow nasal oxygen; Preoxygenation with high flow nasal oxygen, 100% oxygen	Device: High Flow Nasal Oxygen (HFNO); Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a peripheral oxygen saturation (SpO2) below 93%	Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.	From start of anaesthesia until 1 minute after tracheal intubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest median SpO2.	Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation	From start of anaesthesia until 1 minute after tracheal intubation.
End tidal gas levels	Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.	At the first breath after tracheal intubation.
Time span from start of preoxygenation until intubation.	Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.	Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Time span from entering trauma room until intubation.	Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.	Could vary depending on patient and trauma, from a couple of minutes up to an hour.
Difficulties with induction of anaesthesia	Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula	Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Frequency of complications	Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.	Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Wounds and Injuries; Hypoxia
• Other Study ID Numbers: PRIOR-Trauma

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