NCT01924559

Brief Summary

We will investigate the impact biohazard gear has on time to successful intubation and, in particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus, Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video) intubation techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 25, 2016

Completed
Last Updated

May 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1 month

First QC Date

August 6, 2013

Results QC Date

October 6, 2015

Last Update Submit

March 31, 2017

Conditions

Intubation; Difficult

Keywords

Airway

Outcome Measures

Primary Outcomes (1)

  • Time to Successful Intubation

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

    approximately one minute

Study Arms (6)

Direct Laryngoscopy & standard clothing

ACTIVE COMPARATOR

Residents will intubate manikin using DL while wearing standard clothing.

Other: standard clothingDevice: Direct Laryngoscopy

Direct Laryngoscopy & Biohazard Gear

ACTIVE COMPARATOR

Residents will intubate manikins using DL while in Biohazard gear.

Other: Biohazard gearDevice: Direct Laryngoscopy

Glidescope & standard clothing

EXPERIMENTAL

Residents will intubate manikins using Glidescope while wearing standard clothing.

Other: standard clothingDevice: Glidescope

Glidescope & Biohazard Gear

ACTIVE COMPARATOR

Residents will intubate manikins using Glidescope while wearing Biohazard gear.

Other: Biohazard gearDevice: Glidescope

Supraglottic Airway & standard clothing

ACTIVE COMPARATOR

Residents will intubate manikins using Supraglottic Airway while wearing standard clothing.

Other: standard clothingDevice: Supraglottic Airway

Supraglottic Airway and Biohazard gear

ACTIVE COMPARATOR

Residents will intubate manikins using Supraglottic airway while wearing biohazard gear.

Other: Biohazard gearDevice: Supraglottic Airway

Interventions

standard clothingOTHER
Direct Laryngoscopy & standard clothingGlidescope & standard clothingSupraglottic Airway & standard clothing
Biohazard gearOTHER
Direct Laryngoscopy & Biohazard GearGlidescope & Biohazard GearSupraglottic Airway and Biohazard gear
Direct LaryngoscopyDEVICE
Also known as: (the classic standard of care)
Direct Laryngoscopy & Biohazard GearDirect Laryngoscopy & standard clothing
GlidescopeDEVICE
Glidescope & Biohazard GearGlidescope & standard clothing
Supraglottic AirwayDEVICE
Also known as: Supraglottic Airway Laryngopharyngeal Tube
Supraglottic Airway & standard clothingSupraglottic Airway and Biohazard gear

Eligibility Criteria

Age18 Years - 126 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes

You may not qualify if:

  • Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (1)

  • Weaver KR, Barr GC Jr, Long KR, Diaz L Jr, Ratner AS, Reboul JP, Sturm DA, Greenberg MR, Dusza SW, Glenn-Porter B, Kane BG. Comparison of airway intubation devices when using a biohazard suit: a feasibility study. Am J Emerg Med. 2015 Jun;33(6):810-4. doi: 10.1016/j.ajem.2015.02.051. Epub 2015 Mar 6.

    PMID: 25817200RESULT

Limitations and Caveats

Limitations described in associated reference

Results Point of Contact

Title
Marna Rayl Greenberg, DO, MPH
Organization
Lehigh Valley Hospital
Marna.Greenberg@lvh.com
484-884-7514

Study Officials

  • Scott Lipkin, DPM, CIP

    Director, Research Participant Protection Office

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Emergency Medicine Research

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 16, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 9, 2017

Results First Posted

March 25, 2016

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)