Four Methods of Pre-oxygenation

Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers

Four methods of preoxygenation will be compared in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Preoxygenation

Detailed Description

After informed consent, each volunteer will undergo the following techniques:

Simple mask at "flush" flow (40-60 L/min) Non-rebreather mask at 15 L/min Non-rebreather mask at 60 L/min Bag valve mask with one way exhalation valve at 15 L/min

After 3 minutes, the exhaled oxygen will be measured with an oxygen sensor

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years old

Exclusion Criteria:

• Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years)
• pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Preoxygenation; All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes

Device: Preoxygenation; After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed below, the exhaled oxygen content will be measured. All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 15 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Oxygen Concentration	Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing.	Immediately after 3 minutes of oxygen supplementation

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute

Publications and helpful links

General Publications

• Driver BE, Prekker ME, Kornas RL, Cales EK, Reardon RF. Flush Rate Oxygen for Emergency Airway Preoxygenation. Ann Emerg Med. 2017 Jan;69(1):1-6. doi: 10.1016/j.annemergmed.2016.06.018. Epub 2016 Aug 10.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (ESTIMATE): March 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Preox

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED