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

NCT ID: NCT04926337

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-05

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Hypoxia Trauma Rapid Sequence Induction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tight fitting facemask

Preoxygenation with tight facemask, 100% oxygen.

Tight Fitting Facemask

Intervention Type DEVICE

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

High flow nasal oxygen

Preoxygenation with high flow nasal oxygen, 100% oxygen

High Flow Nasal Oxygen (HFNO)

Intervention Type DEVICE

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

Interventions

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Tight Fitting Facemask

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

Intervention Type DEVICE

High Flow Nasal Oxygen (HFNO)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Malin Jonsson Fagerlund

Senior consultant, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malin Jonsson Fagerlund

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital Solna

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PRIOR-Trauma

Identifier Type: -

Identifier Source: org_study_id

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