Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 2:57 PM
Study NCT ID:
NCT02694705
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Preoxygenation Strategies in the Prehospital Environment
Sponsor:
Queen Mary University of London
Organization:
Study Overview
Official Title:
Assessment of Preoxygenation Strategies in the Prehospital Environment
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: