Effect of Head Tilting During Nasotracheal Intubation

September 14, 2018 updated by: Jung-Man Lee, Seoul National University Hospital

The Effect of Head Tilting on the Passing of Tracheal Tube Through Nasopharynx During Nasotracheal Intubation

The goal of this prospective randomized controlled study is to investigate the effect of head tilting on tracheal tube passing during nasotracheal intubation.

The question which the investigators are trying to answer is: If patient's neck is extented on inserting tracheal tube via nostril, will the E-tube be more easily to pass through nasopharynx to oropharynx without trapping?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For nasotracheal intubation, clinicians do sometimes experience tube trapping at naso/oro-pharyngeal tissue. Application of force to overcome resistance can cause tissue injury leading to bleeding, which can disturb tracheal intubation.

The hypothesis of this study is that the method of 'head tilting' can help easy passing of tracheal tube at naso/oro-pharyngeal pathway without trapping in nasotracheal intubation. The purpose of the present study is to investigate the effect of 'head tilting' on the incidence of trapping of tracheal tube at naso/oro-pharynx when tracheal tube is being advanced into oropharynx via nostril during nasotracheal intubation.

Study Type

Interventional

Enrollment (Actual)

66

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
      • Seoul, Korea, Republic of, 07061
        • Seoul National University Boramae 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

18 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.

Exclusion Criteria:

  • Who doesn't agree to enroll
  • Who has a problem to head tilting position such as C-spine injury.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neutral
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position.
Procedure: Neutral
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position.
Experimental: Head tilting
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position.
Procedure: Head tilting
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tube trapping
Time Frame: During nasotracheal intubation
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians feel resistance in advancement.
During nasotracheal intubation

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jung-Man Lee, M.D.,PhD, SMG-SNU Boramae Medical Center

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)

December 14, 2017

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

July 13, 2018

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-2017-64

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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