Laryngoscope Asssited Lightwand Intubation

NCT ID: NCT01950702

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-12-31

Brief Summary

To evaluate the success rate for intubation of laryngocope 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.

Conditions

Cervical Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lightwand intubation

Intervention Type: 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 After confirmation of precise location via clear light source on anterior neck, endotracheal tube was inserted and withdrawn lightwand.

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.

Group Type: EXPERIMENTAL

Laryngoscope assisted lightwand intubation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Pyoung Park

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee-Pyung Park, MD PhD

Role: STUDY_DIRECTOR

Professor

Eugene Kim, MD

Role: PRINCIPAL_INVESTIGATOR

fellow

Locations

Seoul National University of Hospital

Seoul, Jongno-Gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hee-Pyung Park, MD PhD

Role: CONTACT

hppark@snu.ac.kr

82-2-2072-2466

Eugene Kim, MD

Role: CONTACT

tomomie@hanmail.net

82-2-2072-2469

Facility Contacts

Hee-Pyung Park, MD PhD

Role: primary

hppark@snu.ac.kr

82-2-2072-2466

Eugene Kim, MD

Role: backup

tomomie@hanmail.net

82-2-2072-2469

Other Identifiers

php3

Identifier Type: -

Identifier Source: org_study_id