Assessment of Preoxygenation Strategies in the Prehospital Environment

September 29, 2016 updated by: Christopher Groombridge, Queen Mary University of London
Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Essex
      • Earls Colne, Essex, United Kingdom, CO6 2NS
        • Essex & Herts Air Ambulance Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult volunteers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP
3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.
Device: Continuous Positive Airway Pressure (CPAP)
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
Experimental: BVM
3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.
Device: Bag-Valve-Mask (BVM)
Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
Experimental: NRM
3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.
Device: Non-rebreather Mask (NRM)
Preoxygenation provided by NRM, oxygen flow rate 15 l/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional Expired Oxygen Concentration
Time Frame: 3 minutes
Measure of denitrogenation efficacy
3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Essex and Herts Air Ambulance

Investigators

  • Principal Investigator: Christopher J Groombridge, MBBS, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QMERC2015/69

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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