Comparing Hemodynamic Changes for Intubation With Shikani Intubating Stylet and Macintosh Laryngoscope

Phase 4

Completed

Conditions: Anesthesia

Interventions: Device: Endotracheal Intubation

Registration Number: NCT01271543

Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MacIntosh group	Endotracheal Intubation	-
Shikani optical stylet	Endotracheal Intubation	-

Primary Outcome Measures

Name	Time	Method
Heart Rate and Blood Pressure Double Product	Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.	The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.

Secondary Outcome Measures

Name	Time	Method
Time to Complete Laryngoscopy and Successful Intubation	Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.