Trial Outcomes & Findings for Four Methods of Pre-oxygenation (NCT NCT02708862)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Immediately after 3 minutes of oxygen supplementation

Results posted on

2019-06-18

Participant Flow

There were 26 total subjects; each did all 4 arms.

Participant milestones

Participant milestones
Measure	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 60 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
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Four Methods of Pre-oxygenation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preoxygenation n=26 Participants 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
Age, Continuous	26 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after 3 minutes of oxygen supplementation

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.

Outcome measures

Outcome measures
Measure	Preoxygenation n=26 Participants 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
Exhaled Oxygen Concentration Simple mask at 60 L/min for 3 minutes	72 % FeO2 Interval 69.0 to 76.0
Exhaled Oxygen Concentration Non-rebreather at 60 L/min for 3 min	86 % FeO2 Interval 84.0 to 88.0
Exhaled Oxygen Concentration Non-rebreather at 15 L/min for 3 min	54 % FeO2 Interval 50.0 to 57.0
Exhaled Oxygen Concentration Bag valve mask at 15 L/min for 3 minutes	77 % FeO2 Interval 74.0 to 81.0

Adverse Events

Simple Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-rebreather at 15 L/Min

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-rebreather at 60 L/Min

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bag Valve Mask at 15 L/Min

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Audrey Hendrickson

HHRI

Phone: 6128737448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place