Comparative Effectiveness of Intubating Devices in the Morbidly Obese

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Device: Video-Mac; Device: Direct Macintosh Laryngoscopy; Device: GlideScope; Device: McGrath

Study type: Interventional

Funder types: Other

Identifiers

NCT01114945

Pro00019199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

121 participants in 4 patient groups

Video-Mac

Experimental group

Description:

Video-Mac device used during intubation procedure

Treatment:

Device: Video-Mac

GlideScope

Experimental group

Description:

GlideScope device used during intubation procedure

Treatment:

Device: GlideScope

McGrath

Experimental group

Description:

McGrath device used during intubation procedure

Treatment:

Device: McGrath

Direct Macintosh Laryngoscopy

Active Comparator group

Description:

Direct Macintosh Laryngoscopy (DL) used during intubation procedure

Treatment:

Device: Direct Macintosh Laryngoscopy