Laryngoscope Asssited Lightwand Intubation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01950702
First received: September 11, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Cervical Spine Surgery
Procedure: Laryngoscope assisted lightwand intubation
Procedure: Lightwand intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Laryngoscope Assisted Lightwand Can Provide More Successful Intubation Than Lightwand Alone in Patients With Cervical Spine Injury : A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The success rate of intubation [ Time Frame: up to 60 seconds ] [ Designated as safety issue: No ]
    confirm the success intubation via end tidal CO2 measurement


Secondary Outcome Measures:
  • light wand search time [ Time Frame: from the insertion of the lightwand or laryngoscope into the oral cavity to the point of transillumination over the cricothyroid membrane within 60 sec. ] [ Designated as safety issue: No ]
    Check the time(sec) from insertion of the lightwand or laryngoscopy into the oral cavity to push the endotracheal tube into the trachea.

  • The times of scooping of lightwand [ Time Frame: within 1min after insertion of lightwand ] [ Designated as safety issue: No ]
    Within 1min after insertion of lightwand into oral cavity, check the scooping time of lightwand during intubation.


Other Outcome Measures:
  • score of postoperative sorethroat [ Time Frame: at postanesthetic care unit (PACU) within 1hr after end of anesthesia ] [ Designated as safety issue: No ]
    check the postoperative sorethroat at PACU in each patient. Numeric rating scale(NRS) was used to measure the severity of pain 0 to 10.

  • other possible postoperative complications [ Time Frame: just after extubation, an expected average of 1hr ] [ Designated as safety issue: No ]
    tinged blood to endotracheal tube or in oral cavity. hoarseness


Estimated Enrollment: 168
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950702

Contacts
Contact: Hee-Pyung Park, MD PhD 82-2-2072-2466 hppark@snu.ac.kr
Contact: Eugene Kim, MD 82-2-2072-2469 tomomie@hanmail.net

Locations
Korea, Republic of
Seoul National University of Hospital Recruiting
Seoul, Jongno-Gu, Korea, Republic of, 110-799
Contact: Hee-Pyung Park, MD PhD    82-2-2072-2466    hppark@snu.ac.kr   
Contact: Eugene Kim, MD    82-2-2072-2469    tomomie@hanmail.net   
Principal Investigator: Hee-Pyung Park, MD         
Principal Investigator: Eugene Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Hee-Pyung Park, MD PhD Professor
Principal Investigator: Eugene Kim, MD fellow
  More Information

No publications provided

Responsible Party: Hee-Pyoung Park, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01950702     History of Changes
Other Study ID Numbers: php3
Study First Received: September 11, 2013
Last Updated: March 21, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014