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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Vaida, Penn State University
ClinicalTrials.gov Identifier:
NCT01271543
First received: January 5, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Anesthesia
Device: Endotracheal Intubation
Phase 4

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

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Heart Rate and Blood Pressure Double Product [ Time Frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. ] [ Designated as safety issue: Yes ]
    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:
  • Time to Complete Laryngoscopy and Successful Intubation [ Time Frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MacIntosh group 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.
Experimental: Shikani optical stylet 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01271543

Locations
United States, Pennsylvania
PennState Hershey Medical Center
Hershey, Pennsylvania, United States, 17036
Sponsors and Collaborators
Penn State University
  More Information

No publications provided

Responsible Party: Sonia Vaida, M.D, Vice Chair for Reasearch, Penn State University
ClinicalTrials.gov Identifier: NCT01271543     History of Changes
Other Study ID Numbers: IRB 35113, IRB protocol 35113
Study First Received: January 5, 2011
Results First Received: January 31, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Comparison of hemodynamic
endotracheal intubation
changes induced by
performed
the aid of the SOS
as compared to the Macintosh Laryngoscope

ClinicalTrials.gov processed this record on November 20, 2014