Trial Outcomes & Findings for Comparison of Airway Intubation Devices When Using a Biohazard Suit (NCT NCT01924559)

NCT ID: NCT01924559

Last Updated: 2017-05-09

Results Overview

Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

approximately one minute

Results posted on

2017-05-09

Participant Flow

Participant milestones

Participant milestones
Measure
All Study Participants
All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..
Overall Study
STARTED
37
Overall Study
COMPLETED
37
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Airway Intubation Devices When Using a Biohazard Suit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SALT and Biohazard Gear
n=37 Participants
All participants were tested on three intubation devices in either standard clothing or biohazard gear.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
37 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Sex: Female, Male
Female
10 Participants
n=99 Participants
Sex: Female, Male
Male
27 Participants
n=99 Participants

PRIMARY outcome

Timeframe: approximately one minute

Population: EM Residents who tested/participated in each of the six groups

Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute

Outcome measures

Outcome measures
Measure
DL & Standard Clothing
n=37 Participants
Residents will intubate manikin using DL while wearing standard clothing. standard clothing DL
DL & Biohazard Gear
n=37 Participants
Residents will intubate manikins using DL while in Biohazard gear. Biohazard gear DL
Glidescope & Standard Clothing
n=37 Participants
Residents will intubate manikins using Glidescope while wearing standard clothing. standard clothing Glidescope
Glidescope & Biohazard Gear
n=37 Participants
Residents will intubate manikins using Glidescope while wearing Biohazard gear. Biohazard gear Glidescope
SALT & Standard Clothing
n=37 Participants
Residents will intubate manikins using SALT while wearing standard clothing. standard clothing SALT
SALT and Biohazard Gear
n=37 Participants
Residents will intubate manikins using SALT while wearing biohazard gear. Biohazard gear SALT
Time to Successful Intubation
54 seconds
Interval 25.0 to 189.0
106.5 seconds
Interval 29.0 to 534.0
66 seconds
Interval 19.0 to 298.0
83.5 seconds
Interval 25.0 to 375.0
73.5 seconds
Interval 13.0 to 328.0
58.5 seconds
Interval 20.0 to 168.0

Adverse Events

DL & Standard Clothing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DL & Biohazard Gear

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Glidescope & Standard Clothing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Glidescope & Biohazard Gear

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SALT & Standard Clothing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SALT and Biohazard Gear

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

Marna Rayl Greenberg, DO, MPH

Lehigh Valley Hospital

Phone: 484-884-7514

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place