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Completed

NCT Number: NCT01114945

Comparative Effectiveness of Intubating Devices in the Morbidly Obese

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Mcgrath

Device

Intubation with the McGrath device

Glidescope

Device

Intubation with the GlideScope device

Direct Macintosh Laryngoscopy

Device

Intubation with Direct Macintosh Laryngoscope

Video-Mac

Device

Intubation with the Video-Mac device

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 3, 2010
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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