Comparison of Different Tools Inserted Nasal Endotracheal Tube

March 20, 2017 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

A Comparson Among the Use of Direct Laryngoscope.AirwayScope and GlideScope in General Anesthetized Patients Who Require Nasal Endotracheal Tube Intubation

Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. The aim of the study is to compare the efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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
        • 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:

  • patients with American Society of Anesthesiologists physical status I-III
  • aged 20-65 years
  • Requiring Nasotracheal Intubation under general anesthesia

Exclusion Criteria:

  • mouth open < 3 cm
  • limited neck extension < 25 degree
  • Ankylosing arthritis patients.
  • 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: Macintosh Laryngoscope
experimental Macintosh Laryngoscope group: laryngoscope is used to assist for nasotracheal intubation.
Device: Macintosh Laryngoscope
the device is to assist nasotracheal intubation
Other Names:
  • Macintoish laryngoscope
Experimental: Pentax Airway scope
experimental Pentax Airway scope group:Pentax Airway scope is used to assist for nasotracheal intubation.
Device: Pentax Airway scope
the device is to assist the nasotracheal tube into trachea
Experimental: Glidescope
experimental Glidescope group:Glidescope is used to assist nasotracheal tube into trachea
Device: Glidescope
the device is to assist the nasotracheal tube into trachea

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 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 Yi Tseng, M.D., Department of anesthesiology, Kaohsiung Medical University, Taiwan

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

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMUH-IRB-990188

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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