Video-stylet for Nasotracheal Intubation

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

Comparison of Conventional Laryngoscopy and Video-stylet to Assist Nasotracheal Intubation for Patients Undergoing Oro-Maxillo-facial Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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

No

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. unlimited mouth open
  5. unlimited neck motion

Exclusion Criteria:

  1. mouth open < 3 cm
  2. Ankylosing arthritis patients.
  3. 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to intubate
Time Frame: 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.
10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative nasal bleeding, 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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

March 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

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMUH-IRB-20120320

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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