Comparison of Different Tools to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use

November 5, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Comparison Techniques of Magill Forceps and Cuff Inflation to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use

to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill forceps or cuff inflation is advantageous is not determined.

Study Type

Interventional

Enrollment (Actual)

200

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

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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: Magill forceps
experimental Magill forceps group: Magill forceps technique to facilitate nasotracheal tube advancement into trachea
Procedure: Magill forceps
Magill forceps techniques to facilitate nasotracheal tube advancement into trachea
Experimental: cuff inflation
experimental cuff inflation group: cuff inflation technique to facilitate nasotracheal tube advancement into trachea
Procedure: cuff inflation
cuff inflation techniques to facilitate nasotracheal tube advancement into trachea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the technique spending time in this time interval and first attempt successful rate
Time Frame: 10 minutes
to measure the time taken of either using Magill forceps or with cuff inflation techniques in successfully intubated patients
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total intubation time taken
Time Frame: half an hour
measure the whole intubation time taken from tube tip into selected nostril, to nasopharynx, to oropharynx, into trachea, till capnography showing of 3 consecutive CO2 waveforms
half an hour
glottic injury and cuff damages during tube advanced
Time Frame: half an hour
to assess the bleeding point of glottic area and the cuff injury of endotracheal tube
half an hour
postoperative nasal bleeding, sore throat and hoarseness
Time Frame: 2 days
Events of intubating related nasal bleeding were measured on selected nostril and oral cavity at 3 minutes post-intubation. Incidences of sore throat and hoarseness are evaluated before patients out of recovery room and the coming 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

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 (Actual)

March 31, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMUHIRB-F(II)-20150058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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