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

NCT01271543 | Completed Phase 4 Results

• 2 other identifiers: IRB 35113IRB protocol 35113
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Comparison of hemodynamic; endotracheal intubation; changes induced by; performed; the aid of the SOS; as compared to the Macintosh Laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

MacIntosh group

ACTIVE COMPARATOR

Device: Endotracheal Intubation

Shikani optical stylet

EXPERIMENTAL

Device: Endotracheal Intubation

Interventions

Endotracheal Intubation DEVICE

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.

MacIntosh group; Shikani optical stylet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

PennState Hershey Medical Center

Hershey, Pennsylvania, 17036, United States

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Limitations and Caveats

NO adverse events

Results Point of Contact

• Title: Sonia Vaida
• Organization: Penn State Milton S. Hershey Medical Center

svaida@hmc.psu.edu

7175318433

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Vice Chair for Reasearch

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 15, 2016
• Results First Posted: December 30, 2013

Record last verified: 2016-03

Locations

US (1)