Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube

October 26, 2020 updated by: Younghoon Jeon, Kyungpook National University Hospital

Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Nasal Endotracheal Tube and a Cylindrical-shaped Cuffed Nasal Endotracheal Tube After Changing in Position of Head

This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.

Study Type

Interventional

Enrollment (Actual)

52

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

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who were underwent nasal intubation

Exclusion Criteria:

  • history of difficult intubation, limited neck movement, respiratory diseases and body mass index more than 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
Active Comparator: cylindrical tube group
The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube.
Device: cylindrical endotracheal tube
endotracheal tube is intubated
Experimental: tapergaurd tube group
The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube.
Device: TaperGuard endotracheal tube
TaperGuard endotracheal tube is intubated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cuff pressure
Time Frame: 5 minutes after change of head position
Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).
5 minutes after change of head position

Collaborators and Investigators

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

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Younghoon Jeon, Mr, kyungook national university 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 (Actual)

January 10, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-11-043-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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