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Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01917435
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
17
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients.

Condition or Disease Intervention/Treatment Phase
  • Device: video-stylet
  • Device: fiberoptic bronchoscope
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Nasotracheal Intubation Assisted by a Video-stylet in Limited Mouth Opening Patient
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Jan 1, 2014
Anticipated Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: fiberoptic bronchoscope

Experimental: fiberoptic bronchoscope fiberoptic bronchoscope is used to facilitate for nasotracheal intubation.

Device: fiberoptic bronchoscope
Other Names:
  • fiberscope

    		•
    Experimental: video-stylet

    Experimental: video-stylet video-stylet is used to facilitate for nasotracheal intubation.

    Device: video-stylet
    Other Names:
  • Device: video-stylet
  • Other Names:
  • The Clarus Video System

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Nasotracheal intubation is assisted by a video-stylet may be performed in patients undergoing Limited Mouth Opening following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg) and is facilitated by cis-atracurium 0.2 mg/kg administration. propofol 1 mg/kg intravenously to blunt hemodynamic responses while intubation. a modified intubation difficulty scale to evaluate the difficulty of fiber-scope guided or trachway assisted nasotracheal intubation

    Secondary Outcome Measures

    1. time to intubate [half an hour]

      time of Intubating the nasotracheal tube (NT) from selected nostril to trachea is continuously calculated but separately into two parts. part one: from leaving off mask ventilation (mask removal 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. perioperative epistaxis, 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. limited mouth open ,mouth open < 3 cm

    5. unlimited neck motion

    Exclusion Criteria:

    1. Ankylosing arthritis patients.

    2. 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

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT01917435
    Other Study ID Numbers:
    • KMUH-IRB-20120254
    First Posted:
    Aug 6, 2013
    Last Update Posted:
    Aug 6, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    fiberoptic bronchoscopy,
    Video-stylet,
    Nasotracheal Intubation

    Study Results

    No Results Posted as of Aug 6, 2013