Comparing Hemodynamic Changes for Intubation With Shikani Intubating Stylet and Macintosh Laryngoscope
Information source: Penn State University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Intervention: Endotracheal Intubation (Device)
Phase: Phase 4
Status: Completed
Sponsored by: Penn State University
Summary
Because of its simplicity of function and reliability, direct laryngoscopy it is routinely
used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is
fraught with concerns for cardiovascular stimulation during induction of general anesthesia.
This can be attributed to the placement of the laryngoscope blade into the vallecula and
then applying force in an upward direction to expose the glottic opening. The average force
necessary for visualization of the glottic opening is approximately 5. 4kg. This can lead to
significant pressor responses and tachycardia though stimuli to supraglottic region.
An alternative airway management device is the Shikani optical stylet (SOS). It is an
effective, safe and reusable intubation device that has been shown to be effective in cases
of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable
stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment
to a light source. An adjustable "tube stop" firmly affixes the endotracheal tube to the
stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the
stylet with the loaded endotracheal tube into the patient's oropharynx and under direct
visualization through the eyepiece, is able to visualize the vocal cords. Because the end
of the stylet is at the end of the endotracheal tube, it can be directly visualized to be
entering trachea past the vocal cords.
The investigators hypothesize that endotracheal intubation performed by the aid of SOS by
minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in
patients with normal airways as compared with the MacIntosh laryngoscope.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Heart Rate and Blood Pressure Double Product
Secondary outcome: Time to Complete Laryngoscopy and Successful Intubation
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 - 75 years, ASA I and II, normotensive, Mallampati class: I and II, thyromental
distance > than 6. 5 cm, interincisor distance > than 3 cm, BMI < 35 Kg/m2
Exclusion Criteria:
- Exclusion criteria: pregnant patients, known or expected difficult airway,
gastroesophageal reflux, esophageal pathology, pulmonary pathology, cardiovascular
pathology.
Locations and Contacts
PennState Hershey Medical Center, Hershey, Pennsylvania 17036, United States
Additional Information
Starting date: February 2011
Last updated: November 12, 2013
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