Laryngoscope Asssited Lightwand Intubation

Laryngoscope Assisted Lightwand Can Provide More Successful Intubation Than Lightwand Alone in Patients With Cervical Spine Injury : A Prospective Randomized Study

To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.

Study Overview

• Status: Unknown
• Conditions: Cervical Spine Surgery
• Intervention / Treatment: Procedure: Lightwand intubation; Procedure: Laryngoscope assisted lightwand intubation

Detailed Description

Light wand intubation is well known for safety intubation in cervical injury patiets. Traditional method of using light wand can damage the supraglottic cavity by scooping the apparatus. The investigators try to evaluate the efficacy of laryngoscope assisted light wand intubation compared to traditional method of using light wand alone.

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-Gu
    • Seoul, Jongno-Gu, Korea, Republic of, 110-799
      • Recruiting
      • Seoul National University of Hospital
      • Contact: Eugene Kim, MD; Phone Number: 82-2-2072-2469; Email: tomomie@hanmail.net
      • Principal Investigator: Eugene Kim, MD
      • Contact: Hee-Pyung Park, MD PhD; Phone Number: 82-2-2072-2466; Email: hppark@snu.ac.kr
      • Principal Investigator: Hee-Pyung Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient scheduled for cervical spine surgery under general anesthesia

Exclusion Criteria:

• congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation, or foreign bodies in the upper airway
• history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
• American Society of Anesthesiologists physical status ≥ 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lightwand intubation; After standard total intravenous anesthesia using propofol and remifentanil continuous infusion, traditional lightwand intubation was done by pre-specified anesthesiologist who experienced more than 100 times of lightwand intubation. Patient's head were fixed at neutral position during all intubation period.	Procedure: Lightwand intubation; After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen. Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position. After 2min from administration of rocuronium, the clinician holds the wand similar to a pencil, stands directly behind the patient's head, inserts the device into the side of the mouth and sweeps the tip to the midline. After confirmation of precise location via clear light source on anterior neck, endotracheal tube was inserted and withdrawn lightwand.; Other Names: Surch-Lite, Aaron Medical Industries, St. Petersburg, FL
Experimental: Laryngoscope assisted lightwand intubation; After standard total intravenous anesthesia using propofol and remifentanil continuous infusion, lightwand intubation using specific device(Macintosh laryngosope, female:3/Male:4) was done by pre-specified anesthesiologist who experienced more than 100 times of laryngoscope assisted lightwand intubation.	Procedure: Laryngoscope assisted lightwand intubation; After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen. Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position. The Macintosh laryngoscope (female: 3rd blade, male: 4th blade) was inserted into the oral cavity to provide direct view of the epiglottis and then the tip of the lightwand was placed below the epiglottis.; Other Names: The Macintosh laryngoscope (female: 3rd blade, male: 4th blade); lightwand (Surch-Lite, Aaron Medical Industries, St. Petersburg, FL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of intubation	confirm the success intubation via end tidal CO2 measurement	up to 60 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lightwand search (=intubation) time	Check the time(sec) from insertion of the lightwand or laryngoscopy into the oral cavity to push the endotracheal tube into the trachea.	from the insertion of the lightwand or laryngoscope into the oral cavity to the point of transillumination over the cricothyroid membrane within 60 sec.
The times of scooping of lightwand	Within 1min after insertion of lightwand into oral cavity, check the scooping time of lightwand during intubation.	within 1min after insertion of lightwand

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of postoperative sorethroat	check the postoperative sorethroat at PACU in each patient. Numeric rating scale(NRS) was used to measure the severity of pain 0 to 10.	at postanesthetic care unit (PACU) within 1hr after end of anesthesia
Incidence of moderate to severe postoperative sorethroat	check the postoperative sorethroat >3 at PACU in each patient. Numeric rating scale(NRS) was used to measure the severity of pain 0 to 10. 0-3 : mild 4-7 : moderate 8-10 : severe	at postanesthetic care unit (PACU) within 1hr after end of anesthesia
other possible postoperative complications	tinged blood to endotracheal tube or in oral cavity. hoarseness	just after extubation, an expected average of 1hr

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Hee-Pyung Park, MD PhD, Professor; Principal Investigator: Eugene Kim, MD, Fellow

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 22, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: php3