Laryngoscope Asssited Lightwand Intubation

Cervical Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01950702
• Other study ID #: php3
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2013
• Last updated: October 22, 2014
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2014
• Source: Seoul National University Hospital
• Contact: Hee-Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cervical Spine Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul	Jongno-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	other possible postoperative complications	tinged blood to endotracheal tube or in oral cavity. hoarseness	just after extubation, an expected average of 1hr	No
Primary	The success rate of intubation	confirm the success intubation via end tidal CO2 measurement	up to 60 seconds	No
Secondary	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.	No
Secondary	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	No