Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Other: Flush rate oxygen; Other: Flush rate oxygen with assist

• Registration Number: NCT02841592
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-22
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-28
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Age >17

Exclusion Criteria

• Pregnant
• Any facial hair more than stubble that might impede a mask seal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-rebreather	Flush rate oxygen	This group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention
Bag-valve-mask	Flush rate oxygen with assist	With each inspiration from the subject, the ventilation bag will be gently squeezed to provide positive pressure and augment the amount of oxygen that is received by the subject for each breath. This group will receive the flush rate oxygen with assist intervention.

Primary Outcome Measures

Name	Time	Method
Fraction of expired oxygen	3 minutes	The fraction of expired oxygen will be measured after three minutes of preoxygenation

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States