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Trial record 14 of 17 for:    Open Studies | "Voice Disorders"

Rigid Video Stylet Vs Conventional Lightwand Intubation (Optiscope)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02073786
First received: February 21, 2014
Last updated: October 23, 2014
Last verified: February 2014
  Purpose

Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.


Condition Intervention
Hoarseness
Intubation
Sorethroat
Device: Conventional lightwand intubation
Device: Rigid video stylet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: : Rigid Video Stylet Can Provide More Successful Intubation Than Conventional Lightwand Intubation in Patients With Cervical Spine Operation : A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Primary success rate of intubation [ Time Frame: within 90 sec from insertion of device ] [ Designated as safety issue: Yes ]
    compare primary success rate of intubation using Optiscope with lightwand intubation


Secondary Outcome Measures:
  • Intubation time [ Time Frame: within 90 seconds from insertion of device ] [ Designated as safety issue: No ]
    Check the intubation time (sec) Intubation time defines "from insertion of device to oral cavity of patients to confirm successful intubation"

  • postoperative complications [ Time Frame: During PACU stay time expected up to 1hr ] [ Designated as safety issue: No ]
    check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score

  • hemodynamic change [ Time Frame: baseline and 1minute after intubation ] [ Designated as safety issue: No ]
    check the changes of mean blood pressure, heart rate, pulse oximetry before and after intubation

  • number of intubation trial and scooping movements [ Time Frame: during intubation time, an expected average of 1minute ] [ Designated as safety issue: No ]
    Check the number of intubation tiral and scooping movements during intubation


Estimated Enrollment: 168
Study Start Date: October 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lightwand
Conventional lightwand intubation will performe for intubation
Device: Conventional lightwand intubation
Conventional lightwand intubation technique will perform during intubation
Experimental: Optiscope
Rigid video stylet, manufactural named Optiscope, will perform for intubation
Device: Rigid video stylet
Rigid video stylet will inserted through endotracheal tube before induction. After induction with propofol and remifentanil using TIVA infusion pump, rocuronium 0.6mg/kg were used to facilitate intubation. After 2minutes, board-certificated anesthesiologist perform intubation using Optiscope.
Other Name: Optiscope® (Pacific Medical, Seoul, Republic of Korea)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for cervical spine surgery under general anesthesia
  • aged between 20- 80 yrs

Exclusion Criteria:

  • Patient who disagrees to participate this study
  • Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
  • Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway
  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: NCT02073786

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, 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   
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: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02073786     History of Changes
Other Study ID Numbers: Optiscope_SNUH
Study First Received: February 21, 2014
Last Updated: October 23, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hoarseness
Laryngeal Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Voice Disorders

ClinicalTrials.gov processed this record on November 25, 2014