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Assessment of Preoxygenation Strategies in the Prehospital Environment

Primary Purpose

Anesthesia, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Bag-Valve-Mask (BVM)
Non-rebreather Mask (NRM)
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Oxygen Inhalation Therapy, Intubation, Emergency Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult volunteers

Exclusion Criteria:

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

Sites / Locations

  • Essex & Herts Air Ambulance Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CPAP

BVM

NRM

Arm Description

3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.

3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.

3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.

Outcomes

Primary Outcome Measures

Fractional Expired Oxygen Concentration
Measure of denitrogenation efficacy

Secondary Outcome Measures

Ease of breathing assessment using a visual analogue scale
Visual analogue scale to assess subjective ease of breathing through each device

Full Information

First Posted
February 24, 2016
Last Updated
September 29, 2016
Sponsor
Queen Mary University of London
Collaborators
Essex and Herts Air Ambulance
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1. Study Identification

Unique Protocol Identification Number
NCT02694705
Brief Title
Assessment of Preoxygenation Strategies in the Prehospital Environment
Official Title
Assessment of Preoxygenation Strategies in the Prehospital Environment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary University of London
Collaborators
Essex and Herts Air Ambulance

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Hypoxia
Keywords
Oxygen Inhalation Therapy, Intubation, Emergency Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.
Arm Title
BVM
Arm Type
Experimental
Arm Description
3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.
Arm Title
NRM
Arm Type
Experimental
Arm Description
3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
Intervention Type
Device
Intervention Name(s)
Bag-Valve-Mask (BVM)
Intervention Description
Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
Intervention Type
Device
Intervention Name(s)
Non-rebreather Mask (NRM)
Intervention Description
Preoxygenation provided by NRM, oxygen flow rate 15 l/min
Primary Outcome Measure Information:
Title
Fractional Expired Oxygen Concentration
Description
Measure of denitrogenation efficacy
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Ease of breathing assessment using a visual analogue scale
Description
Visual analogue scale to assess subjective ease of breathing through each device
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult volunteers Exclusion Criteria: Pregnancy Respiratory disease Bearded Facial abnormality Edentulous
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Groombridge, MBBS
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Essex & Herts Air Ambulance Trust
City
Earls Colne
State/Province
Essex
ZIP/Postal Code
CO6 2NS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26728311
Citation
Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.
Results Reference
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Assessment of Preoxygenation Strategies in the Prehospital Environment

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