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Assessment of Preoxygenation Strategies in the Prehospital Environment

Assessment of Preoxygenation Strategies in the Prehospital Environment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02694705
Enrollment
30
Registered
2016-02-29
Start date
2016-02-29
Completion date
2016-07-31
Last updated
2016-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hypoxia

Keywords

Oxygen Inhalation Therapy, Intubation, Emergency Medicine

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).

Interventions

DEVICEContinuous Positive Airway Pressure (CPAP)

CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator

DEVICEBag-Valve-Mask (BVM)

Preoxygenation provided by BVM device, oxygen flow rate 15 l/min

Preoxygenation provided by NRM, oxygen flow rate 15 l/min

Sponsors

Essex and Herts Air Ambulance
CollaboratorOTHER
Queen Mary University of London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult volunteers

Exclusion criteria

* Pregnancy * Respiratory disease * Bearded * Facial abnormality * Edentulous

Design outcomes

Primary

MeasureTime frameDescription
Fractional Expired Oxygen Concentration3 minutesMeasure of denitrogenation efficacy

Secondary

MeasureTime frameDescription
Ease of breathing assessment using a visual analogue scale3 minutesVisual analogue scale to assess subjective ease of breathing through each device

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026