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

NCT04926337 | Completed

• 1 other identifier: PRIOR-Trauma
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Hypoxia; Trauma; Rapid Sequence Induction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Lowest median SpO2.

  From start of anaesthesia until 1 minute after tracheal intubation.

• End tidal gas levels

  At the first breath after tracheal intubation.

• Time span from start of preoxygenation until intubation.

  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.

  Could vary depending on patient and trauma, from a couple of minutes up to an hour.

• Difficulties with induction of anaesthesia

  Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.

Study Arms (2)

Tight fitting facemask

Preoxygenation with tight facemask, 100% oxygen.

Device: Tight Fitting Facemask

High flow nasal oxygen

Preoxygenation with high flow nasal oxygen, 100% oxygen

Device: High Flow Nasal Oxygen (HFNO)

Interventions

Tight Fitting Facemask DEVICE

Preoxygenation with tight facemask, 10 L/min, 100% oxygen.

Tight fitting facemask

High Flow Nasal Oxygen (HFNO) DEVICE

Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.

High flow nasal oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital Solna

Stockholm, SE-17176, Sweden

Location

MeSH Terms

Conditions

Hypoxia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Malin Jonsson Fagerlund

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, Associate Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 15, 2021
• Study Start: June 1, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

SE (1)