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

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271543
• Other study ID #: IRB 35113
• Secondary ID: IRB protocol 351
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2011
• Last updated: November 12, 2013
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Endotracheal Intubation
General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size) or MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for male in both groups. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.

Locations

Country	Name	City	State
United States	PennState Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate and Blood Pressure Double Product	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.	Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.	Yes
Secondary	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.	Yes