LaryngoscopyNCT00602979
Comparison Study in Adult Surgical Patients of 5 Airway Devices
A study testing Macintosh laryngoscope, Airtraq® Optical Laryngoscope and Storz DCI Video Laryngoscope® in people with Laryngoscopy and Intubation, run by Weill Medical College of Cornell University.
Trial summary
The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a light source-that allow examination of the upper airway through the mouth, often for the purposes of intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngoscopy, Intubation
- What is being tested?
- Macintosh laryngoscope, Airtraq® Optical Laryngoscope and Storz DCI Video Laryngoscope®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jul 2011
- 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
- Elective adult surgical patient requiring general endotracheal anesthesia.
- Males and Females.
- ASA Physical Status 1-3.
- Age 18 years of age and older
- Subject's refusal or inability to agree to and to sign the Informed Consent Form in English.
- Subject requiring awake airway management.
Who cannot join
- Body Mass Index (BMI) ≥35kg/m2.
- If subject is of childbearing potential, a positive pregnancy test at the time of study enrollment.
- Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
- Intubated prior to surgery.
- Severe cardiovascular, hepatic or renal disease.
- Need for nasal intubation.
- An investigator of this study.
About this study
Official title: Prospective, Randomized Comparison of Intubating Conditions With Airtraq Optical, Storz DCI Video, McGRATH Video, GlideScope Video, & Macintosh Laryngoscope in Randomly Selected Elective Adult Surgical Patients
The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a light source-that allow examination of the upper airway through the mouth, often for the purposes of intubation. Recently some new laryngoscope devices (including the Airtraq® Optical Laryngoscope, the Storz DCI Video laryngoscope®, McGRATH® Video Laryngoscope, and the GlideScope®) have been developed, which may either decrease the stress related to intubation (reduce neck extension, reduce risk of complications or reduce time elapsed during intubation) or improve intubation success (reduce the number of attempts at intubating). Data are being collected in this study to determine which of these commonly-used devices may be better, particularly in comparison to the current hospital standard, the Macintosh laryngoscope. All of the devices to be used in this study are currently cleared or exempt by the Food and Drug Administration (FDA).
Read the detailed description
Historically, optical and video laryngoscopes have been used as alternative airway management devices for the difficult airway, and as rescue devices. Their use by experienced laryngoscopists has not been compared in a prospective, randomized, head-to-head comparison for routine airway management in adult surgical patients. Video and optical laryngoscopes have been developed to improve the laryngeal view for tracheal intubation and to decrease physiological stress associated with the procedure. The objective of this study is to determine whether these devices offer superior intubating conditions for routine surgical management, over the Macintosh laryngoscope, which is the current standard. The devices to be compared in this study are the most commonly used video and optical laryngoscopes on the market and are cleared or exempt by the Food and Drug Administration (FDA).
Eligible subjects include elective adult surgical patients with an ASA status between 1 and 3 requiring general endotracheal anesthesia. Subjects with a BMI ≥ 40, or undergoing surgery in close proximity to the neck will be excluded. Prior to surgery, subjects will receive a pre-anesthesia evaluation with particular attention to the airway using the Mallampati classification system; atlanto-occipital joint extension; thyro-mental distance; temporomandibular joint function; inter-incisor distance; and dental assessment. Subjects will be randomized for intubation with one of the five laryngoscopes in equal proportions. The following data were recorded: total intubation time, maximum neck extension using an angle gauge, glottic view, assessed by the anesthesiologist using the Cook modification of the Cormack-Lehane grading system (Figure 1), and ease of tracheal intubation using a 5-point rating scale; 5 (excellent) to 1 (poor). Subjects were queried about soreness or painful swallowing in the PACU and a week later via a phone call.
- Conditions
- Laryngoscopy, Intubation
- Being tested
- Macintosh laryngoscope, Airtraq® Optical Laryngoscope, Storz DCI Video Laryngoscope®, GlideScope® Video Laryngoscope, McGRATH® Video Laryngoscope
- Keywords
- endotracheal intubation, intubation, laryngoscopy, laryngoscope, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
Used during laryngoscopy to facilitate intubation.
Airtraq® Optical LaryngoscopeDevice
Used during laryngoscopy to facilitate intubation.
Storz DCI Video Laryngoscope®Device
Used during laryngoscopy to facilitate intubation
GlideScope® Video LaryngoscopeDevice
Used during laryngoscopy to facilitate intubation
McGRATH® Video LaryngoscopeDevice
Used during laryngoscopy to facilitate intubation
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Other | Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Receives: Device: Macintosh laryngoscope |
| Airtraq Optical Laryngoscope | Other | Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Receives: Device: Airtraq® Optical Laryngoscope |
| Storz DCI Video Laryngoscope | Other | Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Receives: Device: Storz DCI Video Laryngoscope® |
| GlideScope Video Laryngoscope | Other | GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) Receives: Device: GlideScope® Video Laryngoscope |
| McGRATH Video Laryngoscope | Other | McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) Receives: Device: McGRATH® Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.
Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible.
Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4.
Measured: 1 time during laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionJul 2011
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 LaryngoscopyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- King Systems Corporation, KARL STORZ Endoscopy-America, Inc.
- Responsible party
- Sponsor
- Investigators
- Jon Samuels, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602979
- Sponsor's protocol ID
- 0710009433
- Status last verified
- Apr 2017
- First submitted
- 15 Jan 2008
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cook TM. A new practical classification of laryngeal view. Anaesthesia. 2000 Mar;55(3):274-9. doi: 10.1046/j.1365-2044.2000.01270.x.
PubMed 10671848
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparison of Intubating Conditions With Airtraq Optical, Storz DCI Video, McGRATH Video, GlideScope Video, & Macintosh Laryngoscope in Randomly Selected Elective Adult Surgical Patients
- ClinicalTrials.gov ID
- NCT00602979
- Acronym / sponsor ID
- 0710009433
- Conditions
- Laryngoscopy, Intubation
- Keywords
- endotracheal intubation, intubation, laryngoscopy, laryngoscope, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- King Systems Corporation, KARL STORZ Endoscopy-America, Inc.
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a light source-that allow examination of the upper airway through the mouth, often for the purposes of intubation. Recently some new laryngoscope devices (including the Airtraq® Optical Laryngoscope, the Storz DCI Video laryngoscope®, McGRATH® Video Laryngoscope, and the GlideScope®) have been developed, which may either decrease the stress related to intubation (reduce neck extension, reduce risk of complications or reduce time elapsed during intubation) or improve intubation success (reduce the number of attempts at intubating). Data are being collected in this study to determine which of these commonly-used devices may be better, particularly in comparison to the current hospital standard, the Macintosh laryngoscope. All of the devices to be used in this study are currently cleared or exempt by the Food and Drug Administration (FDA).
Detailed description
Historically, optical and video laryngoscopes have been used as alternative airway management devices for the difficult airway, and as rescue devices. Their use by experienced laryngoscopists has not been compared in a prospective, randomized, head-to-head comparison for routine airway management in adult surgical patients. Video and optical laryngoscopes have been developed to improve the laryngeal view for tracheal intubation and to decrease physiological stress associated with the procedure. The objective of this study is to determine whether these devices offer superior intubating conditions for routine surgical management, over the Macintosh laryngoscope, which is the current standard. The devices to be compared in this study are the most commonly used video and optical laryngoscopes on the market and are cleared or exempt by the Food and Drug Administration (FDA).
Eligible subjects include elective adult surgical patients with an ASA status between 1 and 3 requiring general endotracheal anesthesia. Subjects with a BMI ≥ 40, or undergoing surgery in close proximity to the neck will be excluded. Prior to surgery, subjects will receive a pre-anesthesia evaluation with particular attention to the airway using the Mallampati classification system; atlanto-occipital joint extension; thyro-mental distance; temporomandibular joint function; inter-incisor distance; and dental assessment. Subjects will be randomized for intubation with one of the five laryngoscopes in equal proportions. The following data were recorded: total intubation time, maximum neck extension using an angle gauge, glottic view, assessed by the anesthesiologist using the Cook modification of the Cormack-Lehane grading system (Figure 1), and ease of tracheal intubation using a 5-point rating scale; 5 (excellent) to 1 (poor). Subjects were queried about soreness or painful swallowing in the PACU and a week later via a phone call.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Other | Device: Macintosh laryngoscopeMacintosh laryngoscope (control group/direct laryngoscopy) - current standard |
| Airtraq Optical Laryngoscope | Other | Device: Airtraq® Optical LaryngoscopeAirtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) |
| Storz DCI Video Laryngoscope | Other | Device: Storz DCI Video Laryngoscope®Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) |
| GlideScope Video Laryngoscope | Other | Device: GlideScope® Video LaryngoscopeGlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) |
| McGRATH Video Laryngoscope | Other | Device: McGRATH® Video LaryngoscopeMcGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elective adult surgical patient requiring general endotracheal anesthesia.
- Males and Females.
- ASA Physical Status 1-3.
- Age 18 years of age and older
- Subject's refusal or inability to agree to and to sign the Informed Consent Form in English.
Key exclusion criteria (7 listed)
- Body Mass Index (BMI) ≥35kg/m2.
- If subject is of childbearing potential, a positive pregnancy test at the time of study enrollment.
- Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
- Intubated prior to surgery.
- Severe cardiovascular, hepatic or renal disease.
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 |
|---|---|---|
| Macintosh laryngoscopeUsed during laryngoscopy to facilitate intubation. | Device | Macintosh laryngoscope |
| Airtraq® Optical LaryngoscopeUsed during laryngoscopy to facilitate intubation. | Device | Airtraq Optical Laryngoscope |
| Storz DCI Video Laryngoscope®Used during laryngoscopy to facilitate intubation | Device | Storz DCI Video Laryngoscope |
| GlideScope® Video LaryngoscopeUsed during laryngoscopy to facilitate intubation | Device | GlideScope Video Laryngoscope |
| McGRATH® Video LaryngoscopeUsed during laryngoscopy to facilitate intubation | Device | McGRATH Video Laryngoscope |
Primary outcome
Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.
Time frame: 1 time during laryngoscopy
Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible. Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10671848Cook TM. A new practical classification of laryngeal view. Anaesthesia. 2000 Mar;55(3):274-9. doi: 10.1046/j.1365-2044.2000.01270.x.
- 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.
Jon Samuels, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscope, Airtraq® Optical Laryngoscope and Storz DCI Video Laryngoscope® in people with Laryngoscopy and Intubation, run by Weill Medical College of Cornell University.
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 6 inclusion and 7 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 19 May 2017). 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?
Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System. (time frame: 1 time during laryngoscopy). 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 NCT00602979, 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 19 May 2017.