Assessment of Preoxygenation Strategies in the Prehospital Environment

Anesthesia Clinical Trial

Official title:

Assessment of Preoxygenation Strategies in the Prehospital Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694705
• Other study ID #: QMERC2015/69
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: September 29, 2016
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Councils UK
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult volunteers

Exclusion Criteria:

• Pregnancy

• Respiratory disease

• Bearded

• Facial abnormality

• Edentulous

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Hypoxia

Intervention

Device:
• Continuous Positive Airway Pressure (CPAP)
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
• Bag-Valve-Mask (BVM)
Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
• Non-rebreather Mask (NRM)
Preoxygenation provided by NRM, oxygen flow rate 15 l/min

Locations

Country	Name	City	State
United Kingdom	Essex & Herts Air Ambulance Trust	Earls Colne	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Essex and Herts Air Ambulance Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional Expired Oxygen Concentration	Measure of denitrogenation efficacy	3 minutes	No
Secondary	Ease of breathing assessment using a visual analogue scale	Visual analogue scale to assess subjective ease of breathing through each device	3 minutes	No