Comparative Effectiveness of Intubating Devices in the Morbidly Obese

NCT01114945 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00019199
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Direct Laryngoscopy; Video-Mac; GlideScope; McGrath; Laryngoscopy; Bariatrics; Glottic view; Airway intubating devices; Tracheal intubation

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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

  Up to 1 minute

Study Arms (4)

Video-Mac

EXPERIMENTAL

Video-Mac device used during intubation procedure

Device: Video-Mac

GlideScope

EXPERIMENTAL

GlideScope device used during intubation procedure

Device: GlideScope

McGrath

EXPERIMENTAL

McGrath device used during intubation procedure

Device: McGrath

Direct Macintosh Laryngoscopy

ACTIVE COMPARATOR

Direct Macintosh Laryngoscopy (DL) used during intubation procedure

Device: Direct Macintosh Laryngoscopy

Interventions

McGrath DEVICE

Intubation with the McGrath device

McGrath

GlideScope DEVICE

Intubation with the GlideScope device

GlideScope

Direct Macintosh Laryngoscopy DEVICE

Intubation with Direct Macintosh Laryngoscope

Direct Macintosh Laryngoscopy

Video-Mac DEVICE

Intubation with the Video-Mac device

Video-Mac

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Roya Yumul, M.D., Ph.D.
• Organization: Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

(Roya.Yumul@cshs.org)

310-423-5841

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 3, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 6, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-03

Locations

US (1)