Oral IntubationNCT01235065
GlideScope Versus Direct Laryngoscope for Emergency Intubation
A study testing type of laryngoscope in people with Oral Intubation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Intubation
- What is being tested?
- type of laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 623 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 16 Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- require emergency intubation
Who cannot join
- age < 18
- require surgical airway on initial assessment
- have known or strongly suspected spinal cord injury
Trial locations and contacts
1 site in 1 country.
United States1 site
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
About this study
Official title: GlideScope vs. Direct Laryngoscope for Emergency Intubation
The purpose of this study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients.
Read the detailed description
On admission to the emergency department following traumatic injury, many patients require placement of an artificial airway to support their breathing, provide oxygen and protect their airway. This procedure is accomplished through a number of different techniques and few studies have compared these techniques in order to establish the best method. We will compare an older technique using a metal handle and blade that allows for direct visualization of the vocal cords (direct laryngoscopy) to a newer technique that employs a fiberoptic bundle imbedded in a handle that allows indirect visualization of the vocal cords during placement of the artificial airway. The newer technique has the theoretical advantage of being more useful in patients with abnormal airways which are frequently encountered in trauma patients. Since both techniques are currently employed routinely in our institution, we will randomize all trauma admission to have an initial attempt with one of the two techniques in order to perform a randomized, unblinded trial.
- Conditions
- Oral Intubation
- Being tested
- type of laryngoscope
- Keywords
- airway management, trauma, intubation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of laryngoscopeDevice
Also called Macintosh direct laryngoscope vs. GlideScope video laryngoscope
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| direct laryngoscope | Active comparator | emergency intubation with direct laryngoscopy technique Receives: Device: type of laryngoscope |
| video laryngoscope | Active comparator | emergency intubation with video laryngoscopy technique Receives: Device: type of laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Survived to Hospital Discharge
Assessment of whether or not the patient was discharged alive from the study center
Measured: 2 weeks, on average
Secondary outcomes (1)
Length of Time to Perform the Intubation Procedure
How long (seconds) it takes the provider to perform the intubation procedure.
Measured: Up to 100 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJul 2008
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
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.
- Other trials for Oral IntubationStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale Yeatts, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235065
- Sponsor's protocol ID
- HP-00042451
- Status last verified
- Jun 2018
- First submitted
- 22 Oct 2010
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: None exists
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideScope vs. Direct Laryngoscope for Emergency Intubation
- ClinicalTrials.gov ID
- NCT01235065
- Acronym / sponsor ID
- HP-00042451
- Conditions
- Oral Intubation
- Keywords
- airway management, trauma, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients.
Detailed description
On admission to the emergency department following traumatic injury, many patients require placement of an artificial airway to support their breathing, provide oxygen and protect their airway. This procedure is accomplished through a number of different techniques and few studies have compared these techniques in order to establish the best method. We will compare an older technique using a metal handle and blade that allows for direct visualization of the vocal cords (direct laryngoscopy) to a newer technique that employs a fiberoptic bundle imbedded in a handle that allows indirect visualization of the vocal cords during placement of the artificial airway. The newer technique has the theoretical advantage of being more useful in patients with abnormal airways which are frequently encountered in trauma patients. Since both techniques are currently employed routinely in our institution, we will randomize all trauma admission to have an initial attempt with one of the two techniques in order to perform a randomized, unblinded trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct laryngoscope | Active comparator | Device: type of laryngoscopeemergency intubation with direct laryngoscopy technique |
| video laryngoscope | Active comparator | Device: type of laryngoscopeemergency intubation with video laryngoscopy technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- require emergency intubation
Key exclusion criteria (3 listed)
- age < 18
- require surgical airway on initial assessment
- have known or strongly suspected spinal cord injury
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 |
|---|---|---|
| type of laryngoscopeAlso: Macintosh direct laryngoscope vs. GlideScope video laryngoscopePatients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope | Device | direct laryngoscope, video laryngoscope |
Primary outcome
Number of Participants Who Survived to Hospital Discharge
Time frame: 2 weeks, on average
Assessment of whether or not the patient was discharged alive from the study center
1 secondary outcome
Length of Time to Perform the Intubation Procedure
Time frame: Up to 100 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. None exists
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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.
Dale Yeatts, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type of laryngoscope in people with Oral Intubation, run by University of Maryland, Baltimore 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 3 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 1 Jun 2023. 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 1 Jun 2023). 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?
Number of Participants Who Survived to Hospital Discharge (time frame: 2 weeks, on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2023.