Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient

August 4, 2013 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Nasotracheal Intubation Assisted by a Video-stylet in Limited Mouth Opening Patient

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of the patients with successful nasotracheal intubation and scoring modified intubation difficulty scale
Time Frame: 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
half an hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to intubate
Time Frame: 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.
half an hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative epistaxis, sore throat and hoarseness
Time Frame: 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
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

August 4, 2013

First Posted (ESTIMATE)

August 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMUH-IRB-20120254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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