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

Anesthesia Clinical Trial

— PRIOR-Trauma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926337
• Other study ID #: PRIOR-Trauma
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: March 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Hypoxia
• Rapid Sequence Induction
• Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

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