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Video-stylet for Nasotracheal Intubation

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01917409
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
14.9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare conventional laryngoscopy with video-stylet (Trachway) for nasotracheal intubation in patients undergoing oro-maxillo-facial surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: conventional laryngoscopy
  • Device: video-stylet
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Conventional Laryngoscopy and Video-stylet to Assist Nasotracheal Intubation for Patients Undergoing Oro-Maxillo-facial Surgery
Study Start Date :
Dec 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: conventional laryngoscopy

experimental conventional laryngoscopy group: laryngoscope is used to assist for nasotracheal intubation.

Device: conventional laryngoscopy
the device is to assist nasotracheal intubation
Other Names:
  • Macintoish laryngoscope

    		•
    Experimental: video-stylet

    experimental video-stylet group:video-stylet is used to guide nasotracheal tube into trachea

    Device: video-stylet
    the device is to guide the nasotracheal tube into trachea
    Other Names:
  • The Clarus Video System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of the patients with successful nasotracheal intubation and scoring difficult intubation scale [half an hour]

      Nasotracheal intubation assisted by a video-stylet may be performed in patients undergoing oro-maxillo-facial surgery following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg, cis-atracurium 0.2 mg/kg and propofol 1 mg/kg)

    Secondary Outcome Measures

    1. time to intubate [10 minutes]

      time of Intubating the nasotracheal tube (NT) from selected nostril to trachea is continuously calculated but separately into two parts. part one: from termination of mask ventilation and mask removed from face, to the NT tip on the nasopharynx. part two: advancing NT from nasopharynx, through vocal cord into trachea, to present of 3 end tidal carbon dioxide waveforms.

    Other Outcome Measures

    1. postoperative nasal bleeding, sore throat and hoarseness [2 days]

      Events of intubating related nasal bleeding are recorded on selected nostril and oral cavity at 3 minutes post-intubation and post-operatively. Incidences of sore throat and hoarseness are evaluated before patients out of recovery room and the following morning

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. patients with American Society of Anesthesiologists physical status I-III

    2. aged 20-65 years

    3. Requiring Nasotracheal Intubation under general anesthesia

    4. unlimited mouth open

    5. unlimited neck motion

    Exclusion Criteria:

    1. mouth open < 3 cm

    2. Ankylosing arthritis patients.

    3. BMI≧35 kg/m2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

    • Study Director: Kuang I Cheng, MD., PhD., Department of anesthesiology, Kaohsiung Medical University, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT01917409
    Other Study ID Numbers:
    • KMUH-IRB-20120320
    First Posted:
    Aug 6, 2013
    Last Update Posted:
    Aug 6, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    Conventional Laryngoscopy ,
    Video-stylet ,
    Nasotracheal Intubation

    Study Results

    No Results Posted as of Aug 6, 2013