Intubation; DifficultNCT01924559
Comparison of Airway Intubation Devices When Using a Biohazard Suit
A study testing standard clothing, Biohazard gear and Direct Laryngoscopy in people with Intubation; Difficult, run by Lehigh Valley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 126 years
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- standard clothing, Biohazard gear and Direct Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 126 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes
Who cannot join
- Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
About this study
Official title: Comparison of Airway Intubation Devices When Using a Biohazard Suit: A Feasibility Study
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.
Read the detailed description
This study will take place in an academic/training facility at Lehigh Valley Health Network simulating intubation during a bio-terrorism attack. As a part of their usual (standard of care) residency education, the study volunteers will be participating in a day-long airway training course in the Fall of 2013 where each of the tested devices will be introduced and the residents will be able to practice using them on a variety of training mannequins.
As part of this training, the enrolled study subjects will be timed using each of three intubation devices, both with and without wearing biohazard protective gear, for a total of six measurements per resident. Residents will have been assigned chronological numbers as they arrived and signed in for the course. These numbers will be also used for study identification numbers. Subjects will be randomized by odd or even identification numbers as to whether they will make their initial attempt in street clothing or the biohazard suit. This will help control for individual subject's skill learning. The subject will then intubate the same mannequins using each of the tested devices.
The order of devices used will be the same as in actual clinical practice: 1) Direct Laryngoscopy (the classic standard of care), 2) the GlideScope or C-MAC video laryngoscope (fiber-optic technology, which has become increasingly popular among emergency physicians), and 3) the Supraglottic Airway Laryngopharyngeal Tube airway device (an inexpensive, convenient supraglottic device that allows for a blind intubation technique through the device).
Data will be collected, per device, on the time taken and tubes used for each attempt. Demographic information will also be collected from participants such as gender, resident year, prior intubation experience, prior exposure to each of the tested devices, and experience wearing a biohazard suit. Study participants' satisfaction with each of the devices will also be recorded.
- Conditions
- Intubation; Difficult
- Being tested
- standard clothing, Biohazard gear, Direct Laryngoscopy, Glidescope, Supraglottic Airway
- Keywords
- Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard clothingOther
Biohazard gearOther
Direct LaryngoscopyDevice
Also called (the classic standard of care)
GlidescopeDevice
Supraglottic AirwayDevice
Also called Supraglottic Airway Laryngopharyngeal Tube
| Study group | Role | What they receive |
|---|---|---|
| Direct Laryngoscopy & standard clothing | Active comparator | Residents will intubate manikin using DL while wearing standard clothing. Receives: Other: standard clothing; Device: Direct Laryngoscopy |
| Direct Laryngoscopy & Biohazard Gear | Active comparator | Residents will intubate manikins using DL while in Biohazard gear. Receives: Other: Biohazard gear; Device: Direct Laryngoscopy |
| Glidescope & standard clothing | Experimental | Residents will intubate manikins using Glidescope while wearing standard clothing. Receives: Other: standard clothing; Device: Glidescope |
| Glidescope & Biohazard Gear | Active comparator | Residents will intubate manikins using Glidescope while wearing Biohazard gear. Receives: Other: Biohazard gear; Device: Glidescope |
| Supraglottic Airway & standard clothing | Active comparator | Residents will intubate manikins using Supraglottic Airway while wearing standard clothing. Receives: Other: standard clothing; Device: Supraglottic Airway |
| Supraglottic Airway and Biohazard gear | Active comparator | Residents will intubate manikins using Supraglottic airway while wearing biohazard gear. Receives: Other: Biohazard gear; Device: Supraglottic Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Intubation
Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute
Measured: approximately one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Scott Lipkin, DPM, CIP, Study director, Director, Research Participant Protection Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924559
- Sponsor's protocol ID
- PRO00000982
- Status last verified
- Mar 2017
- First submitted
- 6 Aug 2013
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25817200
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Airway Intubation Devices When Using a Biohazard Suit: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01924559
- Acronym / sponsor ID
- PRO00000982
- Conditions
- Intubation; Difficult
- Keywords
- Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Posted 25 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will take place in an academic/training facility at Lehigh Valley Health Network simulating intubation during a bio-terrorism attack. As a part of their usual (standard of care) residency education, the study volunteers will be participating in a day-long airway training course in the Fall of 2013 where each of the tested devices will be introduced and the residents will be able to practice using them on a variety of training mannequins.
As part of this training, the enrolled study subjects will be timed using each of three intubation devices, both with and without wearing biohazard protective gear, for a total of six measurements per resident. Residents will have been assigned chronological numbers as they arrived and signed in for the course. These numbers will be also used for study identification numbers. Subjects will be randomized by odd or even identification numbers as to whether they will make their initial attempt in street clothing or the biohazard suit. This will help control for individual subject's skill learning. The subject will then intubate the same mannequins using each of the tested devices.
The order of devices used will be the same as in actual clinical practice: 1) Direct Laryngoscopy (the classic standard of care), 2) the GlideScope or C-MAC video laryngoscope (fiber-optic technology, which has become increasingly popular among emergency physicians), and 3) the Supraglottic Airway Laryngopharyngeal Tube airway device (an inexpensive, convenient supraglottic device that allows for a blind intubation technique through the device).
Data will be collected, per device, on the time taken and tubes used for each attempt. Demographic information will also be collected from participants such as gender, resident year, prior intubation experience, prior exposure to each of the tested devices, and experience wearing a biohazard suit. Study participants' satisfaction with each of the devices will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Direct Laryngoscopy & standard clothing | Active comparator | Other: standard clothing, Device: Direct LaryngoscopyResidents will intubate manikin using DL while wearing standard clothing. |
| Direct Laryngoscopy & Biohazard Gear | Active comparator | Other: Biohazard gear, Device: Direct LaryngoscopyResidents will intubate manikins using DL while in Biohazard gear. |
| Glidescope & standard clothing | Experimental | Other: standard clothing, Device: GlidescopeResidents will intubate manikins using Glidescope while wearing standard clothing. |
| Glidescope & Biohazard Gear | Active comparator | Other: Biohazard gear, Device: GlidescopeResidents will intubate manikins using Glidescope while wearing Biohazard gear. |
| Supraglottic Airway & standard clothing | Active comparator | Other: standard clothing, Device: Supraglottic AirwayResidents will intubate manikins using Supraglottic Airway while wearing standard clothing. |
| Supraglottic Airway and Biohazard gear | Active comparator | Other: Biohazard gear, Device: Supraglottic AirwayResidents will intubate manikins using Supraglottic airway while wearing biohazard gear. |
Who may qualify
- Ages
- 18 to 126 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes
Key exclusion criteria (1 listed)
- Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard clothing | Other | Direct Laryngoscopy & standard clothing, Glidescope & standard clothing, Supraglottic Airway & standard clothing |
| Biohazard gear | Other | Direct Laryngoscopy & Biohazard Gear, Glidescope & Biohazard Gear, Supraglottic Airway and Biohazard gear |
| Direct LaryngoscopyAlso: (the classic standard of care) | Device | Direct Laryngoscopy & Biohazard Gear, Direct Laryngoscopy & standard clothing |
| Glidescope | Device | Glidescope & Biohazard Gear, Glidescope & standard clothing |
| Supraglottic AirwayAlso: Supraglottic Airway Laryngopharyngeal Tube | Device | Supraglottic Airway & standard clothing, Supraglottic Airway and Biohazard gear |
Primary outcome
Time to Successful Intubation
Time frame: approximately one minute
Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25817200Weaver 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Lipkin, DPM, CIP study director
Director, Research Participant Protection Office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard clothing, Biohazard gear and Direct Laryngoscopy in people with Intubation; Difficult, run by Lehigh Valley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Intubation (time frame: approximately one minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01924559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.