Effect of Different Nasotracheal Tubes on Tube Passage

December 1, 2022 updated by: Chul Ho Chang, Gangnam Severance Hospital

Comparison of the Effect of Tube Type and Intubation Technique on Nasopharyngeal Passage During Nasotracheal Intubation

The purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The hypothesis of this study is that the velvet-soft PVC tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional PVC tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. In addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to PVC tube tip.

Study Type

Interventional

Enrollment (Actual)

150

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

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients who need to nasotracheal intubation for surgery
  • age: 19 years old or more

Exclusion Criteria:

  • patient refusal
  • nasal deformity
  • history of previous moderate degree of epistaxis

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional PVC tube
When performing nasotracheal intubation, clinicians use the conventional PVC tube.
Device: nasotracheal tube (Ring-Adair-Elwin)
different materials for nasotracheal intubation conventional PVC tube
Other Names:
  • nasal RAE (Ring-Adair-Elwin) tube
Device: nasotracheal tube (Ring-Adair-Elwin)
different materials for nasotracheal intubation conventional PVC tube with rubber suction catheter
Other Names:
  • nasal RAE (Ring-Adair-Elwin) tube
EXPERIMENTAL: PVC tube with rubber suction catheter
When performing nasotracheal intubation, clinicians use the conventional PVC tube + rubber suction catheter.
Device: nasotracheal tube (Ring-Adair-Elwin)
different materials for nasotracheal intubation conventional PVC tube
Other Names:
  • nasal RAE (Ring-Adair-Elwin) tube
Device: nasotracheal tube (Ring-Adair-Elwin)
different materials for nasotracheal intubation conventional PVC tube with rubber suction catheter
Other Names:
  • nasal RAE (Ring-Adair-Elwin) tube
EXPERIMENTAL: velvet soft PVC tube
When performing nasotracheal intubation, clinicians use the velvet soft PVC tube.
Device: nasotracheal tube (portex)
different materials for nasotracheal intubation velvet soft PVC tube.
Other Names:
  • portex tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blockade of tube advancement from the nasal cavity to the oral cavity [ during intubation]
Time Frame: During nasotracheal intubation (From the time of insertion of the tube through the nostril to completion of the intubation )
When entering a nasotracheal tube from the nasal cavity to the oral cavity before use of laryngoscope in nasotracheal intubation, clinicians sometimes encounter blockade of in tube advancement. The reason is that the direction of the nasotracheal tube and the posterior wall of the nasopharynx are anatomically perpendicular. When advancing the tube from the nasal cavity to the oral cavity, the researcher will evaluate the presence of blockade of tube advancement in the pharynx. (none / present)
During nasotracheal intubation (From the time of insertion of the tube through the nostril to completion of the intubation )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: During nasotracheal intubation (From the time of insertion of the tube or tube combined with the rubber suction catheter to the completion of nasotracheal intubation)
the total time of nasotracheal intubation: From the time of insertion of the tube or tube combined with the rubber suction to the completion of nasotracheal intubation
During nasotracheal intubation (From the time of insertion of the tube or tube combined with the rubber suction catheter to the completion of nasotracheal intubation)

Collaborators and Investigators

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

Sponsor

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Chul Ho Chnag, Gangnam Severance Hospital

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 (ACTUAL)

January 8, 2021

Primary Completion (ACTUAL)

November 4, 2022

Study Completion (ACTUAL)

November 4, 2022

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2020-0444

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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