Laryngoscope Asssited Lightwand Intubation

NCT01950702 | Unknown DMC

• 1 other identifier: php3
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Spine Surgery

Outcome Measures

Primary Outcomes (1)

• The success rate of intubation

  confirm the success intubation via end tidal CO2 measurement

  up to 60 seconds

Secondary Outcomes (2)

• lightwand search (=intubation) time

  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

Other Outcomes (3)

• score of postoperative sorethroat

  at postanesthetic care unit (PACU) within 1hr after end of anesthesia

• Incidence of moderate to severe postoperative sorethroat

  at postanesthetic care unit (PACU) within 1hr after end of anesthesia

• other possible postoperative complications

  just after extubation, an expected average of 1hr

Study Arms (2)

Lightwand intubation

ACTIVE COMPARATOR

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

Laryngoscope assisted lightwand intubation

EXPERIMENTAL

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

Interventions

Laryngoscope assisted lightwand intubation PROCEDURE

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.

Also known as: The Macintosh laryngoscope (female: 3rd blade, male: 4th blade), lightwand (Surch-Lite, Aaron Medical Industries, St. Petersburg, FL)

Laryngoscope assisted lightwand intubation

Lightwand intubation PROCEDURE

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.

Also known as: Surch-Lite, Aaron Medical Industries, St. Petersburg, FL

Lightwand intubation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for cervical spine surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University of Hospital

Seoul, Jongno-Gu, 110-799, South Korea

RECRUITING

Study Officials

• Hee-Pyung Park, MD PhD

  Professor

  STUDY DIRECTOR

• Eugene Kim, MD

  fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee-Pyung Park, MD PhD

CONTACT

82-2-2072-2466; hppark@snu.ac.kr

Eugene Kim, MD

CONTACT

82-2-2072-2469; tomomie@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

KR (1)