Assessment of Preoxygenation Strategies in the Prehospital Environment

Q

Queen Mary University of London

Status

Completed

Conditions

Hypoxia
Anesthesia

Treatments

Device: Bag-Valve-Mask (BVM)
Device: Continuous Positive Airway Pressure (CPAP)
Device: Non-rebreather Mask (NRM)

Study type

Interventional

Funder types

Other

Identifiers

NCT02694705
QMERC2015/69

Details and patient eligibility

About

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

Full 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).

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult volunteers

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 3 patient groups

CPAP
Experimental group
Description:
3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.
Treatment:
Device: Continuous Positive Airway Pressure (CPAP)
BVM
Experimental group
Description:
3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.
Treatment:
Device: Bag-Valve-Mask (BVM)
NRM
Experimental group
Description:
3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.
Treatment:
Device: Non-rebreather Mask (NRM)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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