Assessment of Preoxygenation Strategies in the Prehospital Environment

Not Applicable

Completed

• Conditions: Anesthesia; Hypoxia
• Interventions: Device: Non-rebreather Mask (NRM); Device: Continuous Positive Airway Pressure (CPAP); Device: Bag-Valve-Mask (BVM)

• Registration Number: NCT02694705
• Lead Sponsor: Queen Mary University of London

Brief Summary

Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.

Detailed Description

Prospective randomised interventional study.

Healthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.

The techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:

1. Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.

2. Bag-valve-mask device (BVM) with 15 l/min oxygen flow.

3. Non-rebreather mask (NRM) device with 15 l/min oxygen flow.

Volunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult volunteers

Exclusion Criteria

• Pregnancy
• Respiratory disease
• Bearded
• Facial abnormality
• Edentulous

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NRM	Non-rebreather Mask (NRM)	3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.
CPAP	Continuous Positive Airway Pressure (CPAP)	3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.
BVM	Bag-Valve-Mask (BVM)	3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.

Primary Outcome Measures

Name	Time	Method
Fractional Expired Oxygen Concentration	3 minutes	Measure of denitrogenation efficacy

Secondary Outcome Measures

Name	Time	Method
Ease of breathing assessment using a visual analogue scale	3 minutes	Visual analogue scale to assess subjective ease of breathing through each device

Trial Locations

Locations (1)

Essex & Herts Air Ambulance Trust; 🇬🇧 Earls Colne, Essex, United Kingdom