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Clinical Trials/NCT01114945
NCT01114945
Completed
Phase 4

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

Cedars-Sinai Medical Center1 site in 1 country121 target enrollmentMay 2010
ConditionsObesity

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Obesity
Sponsor
Cedars-Sinai Medical Center
Enrollment
121
Locations
1
Primary Endpoint
Glottis View Using the Cormack Lehane Score
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
October 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients with a documented body mass index (BMI) of \>
  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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.

Study Sites (1)

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