Four Methods of Pre-oxygenation

Respiratory Failure Clinical Trial

Official title:

Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708862
• Other study ID #: Preox
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2016

Study information

• Verified date: May 2019
• Source: Hennepin Healthcare Research Institute.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Four methods of preoxygenation will be compared in healthy volunteers

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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