ObesityPhase 4NCT01114945

Comparative Effectiveness of Intubating Devices in the Morbidly Obese

A Phase 4 study testing McGrath, GlideScope and Direct Macintosh Laryngoscopy in people with Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used. The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Obesity
What is being tested?: McGrath, GlideScope and Direct Macintosh Laryngoscopy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited States
Study dates: May 2010to Oct 2011
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a documented body mass index (BMI) of >35.
Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
Willingness and ability to sign an informed consent document
18 - 80 years of age
American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

Who cannot join

Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
Emergency surgeries
Pregnancy
The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.
Any other conditions or use of any medication which may interfere with the conduct of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery

This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.

The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.

Read the detailed description

Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.

Conditions: Obesity
Being tested: McGrath, GlideScope, Direct Macintosh Laryngoscopy, Video-Mac
Keywords: Direct Laryngoscopy, Video-Mac, GlideScope, McGrath, Laryngoscopy, Bariatrics, Glottic view, Airway intubating devices, Tracheal intubation
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

McGrathDevice
Intubation with the McGrath device
GlideScopeDevice
Intubation with the GlideScope device
Direct Macintosh LaryngoscopyDevice
Intubation with Direct Macintosh Laryngoscope
Video-MacDevice
Intubation with the Video-Mac device

Study groups in NCT01114945
Study group	Role	What they receive
Video-Mac	Experimental	Video-Mac device used during intubation procedure Receives: Device: Video-Mac
GlideScope	Experimental	GlideScope device used during intubation procedure Receives: Device: GlideScope
McGrath	Experimental	McGrath device used during intubation procedure Receives: Device: McGrath
Direct Macintosh Laryngoscopy	Active comparator	Direct Macintosh Laryngoscopy (DL) used during intubation procedure Receives: Device: Direct Macintosh Laryngoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Intubation Time Using a Stop Watch
Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.
Measured: up to 3 minutes
Time to Obtain Glottis Visualization (Seconds)
It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view.
Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery
Measured: up to 1 minute
Percentage of Glottic Opening (POGO) [%]
POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%.
View of the glottic opening (0-100%) during the intubation process.
Measured: up to 1 minute
Glottis View Using the Cormack Lehane Score
Cormack Lehane score classification:
Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible
Measured: Up to 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Oct 2011

First posted3 May 2010 (estimated)
Study startMay 2010
Primary completionOct 2011
Study completionOct 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.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe 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 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01114945
Sponsor's protocol ID: Pro00019199
Status last verified: Mar 2016
First submitted: 23 Apr 2010
Last updated: 6 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery
ClinicalTrials.gov ID: NCT01114945
Acronym / sponsor ID: Pro00019199
Conditions: Obesity
Keywords: Direct Laryngoscopy, Video-Mac, GlideScope, McGrath, Laryngoscopy, Bariatrics, Glottic view, Airway intubating devices
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: May 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 3 May 2010 (estimated)
Results: Posted 9 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.

The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Video-Mac	Experimental	Device: Video-MacVideo-Mac device used during intubation procedure
GlideScope	Experimental	Device: GlideScopeGlideScope device used during intubation procedure
McGrath	Experimental	Device: McGrathMcGrath device used during intubation procedure
Direct Macintosh Laryngoscopy	Active comparator	Device: Direct Macintosh LaryngoscopyDirect Macintosh Laryngoscopy (DL) used during intubation procedure

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with a documented body mass index (BMI) of >35.
Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
Willingness and ability to sign an informed consent document
18 - 80 years of age
American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

Key exclusion criteria (6 listed)

Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
Emergency surgeries
Pregnancy
The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.

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
McGrathIntubation with the McGrath device	Device	McGrath
GlideScopeIntubation with the GlideScope device	Device	GlideScope
Direct Macintosh LaryngoscopyIntubation with Direct Macintosh Laryngoscope	Device	Direct Macintosh Laryngoscopy
Video-MacIntubation with the Video-Mac device	Device	Video-Mac

Primary outcome

Intubation Time Using a Stop Watch
Time frame: up to 3 minutes
Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.
Time to Obtain Glottis Visualization (Seconds)
Time frame: up to 1 minute
It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view. Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery
Percentage of Glottic Opening (POGO) [%]
Time frame: up to 1 minute
POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%. View of the glottic opening (0-100%) during the intubation process.
Glottis View Using the Cormack Lehane Score
Time frame: Up to 1 minute
Cormack Lehane score classification: Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible

Results and safety

Results posted to the registry on 9 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Video-Mac	30	30
GlideScope	30	30
McGrath	30	30
Direct Macintosh Laryngoscopy	31	31

Primary outcome: Intubation Time Using a Stop Watch

Time frame: up to 3 minutes. Mean (Standard Deviation). Unit: Seconds

Measure	Direct Macintosh Laryngoscopy n = 31	Video-Mac n = 30	GlideScope n = 30	McGrath n = 30
Time to placement of tracheal tube	43 (44)	22 (15)	45 (32)	40 (32)
Time to confirm with CO2 waveform	70 (43)	49 (25)	69 (34)	62 (31)

Population analysed: Times following initial insertion of laryngoscope blade: to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)

Primary outcome: Time to Obtain Glottis Visualization (Seconds)

Time frame: up to 1 minute. Mean (Standard Deviation). Unit: Seconds

Measure	Direct Macintosh Laryngoscopy n = 31	Video-Mac n = 30	GlideScope n = 30	McGrath n = 30
Value	20 (28)	9 (8)	12 (9)	10 (9)

Primary outcome: Percentage of Glottic Opening (POGO) [%]

Time frame: up to 1 minute. Mean (Standard Deviation). Unit: percentage of glottis opening

Measure	Direct Macintosh Laryngoscopy n = 31	Video-Mac n = 30	GlideScope n = 30	McGrath n = 30
Value	57 (41)	84 (20)	87 (16)	91 (11)

Primary outcome: Glottis View Using the Cormack Lehane Score

Time frame: Up to 1 minute. Number. Unit: participants

Measure	Direct Macintosh Laryngoscopy n = 31	Video-Mac n = 30	GlideScope n = 30	McGrath n = 30
Grade 1	12	16	18	23
Grade 2	8	12	10	7
Grade 3	5	2	2	0
Grade 4	6	0	0	0

Population analysed: Cormack Lehane score (grade:1/2/3/4 \[n\])

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Video-Mac	0 of 30 (0%)	0 of 30 (0%)	Not reported
GlideScope	0 of 30 (0%)	0 of 30 (0%)	Not reported
McGrath	0 of 30 (0%)	0 of 30 (0%)	Not reported
Direct Macintosh Laryngoscopy	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Roya Yumul, MD, PhD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing McGrath, GlideScope and Direct Macintosh Laryngoscopy in people with Obesity, run by Cedars-Sinai Medical Center 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 5 inclusion and 6 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 6 Apr 2016. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 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?

Intubation Time Using a Stop Watch (time frame: up to 3 minutes). The study lists 4 primary outcomes in all. 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 NCT01114945.

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 6 Apr 2016.