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Completed

NCT Number: NCT02694705

Assessment of Preoxygenation Strategies in the Prehospital Environment

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essex & Herts Air Ambulance Trust

Earls Colne, Essex, CO6 2NS, United Kingdom

About this study

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:

  • Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.
  • Bag-valve-mask device (BVM) with 15 l/min oxygen flow.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult volunteers

Exclusion criteria

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator

Bag-Valve-Mask (BVM)

Device

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

Non-rebreather Mask (NRM)

Device

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

Primary outcomes

  1. Fractional Expired Oxygen Concentration

    Time frame: 3 minutes

    Measure of denitrogenation efficacy

Secondary outcomes

  1. Ease of breathing assessment using a visual analogue scale

    Time frame: 3 minutes

    Visual analogue scale to assess subjective ease of breathing through each device

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Essex and Herts Air Ambulance

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 29, 2016
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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