The Effect of 'Sniffing Position & Nasal Tip Lifting' in Nasotracheal Intubation

October 12, 2017 updated by: Jung-Man Lee, Seoul National University Hospital

The Effect of 'Sniffing Position & Nasal Tip Lifting' on the Pathway of Tracheal Tube in Nasal Cavity During Nasotracheal Intubation

The goal of this prospective randomized study is to compare the effect of nasal tip lifting during nasotracheal intubation.

The question the investigators are trying to answer is: If the nasal tip is tilted, will the E-tube be more likely to enter the lower passage during nasal intubation?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are three nasal turbinates inside the nasal cavities. Each nasal cavity is divided into four spaces from these nasal turbinates, but the two spaces separated by the upper nasal turbinate are too narrow to be clinically meaningful. So when performing nasotracheal intubation, the tube enters one of the two spaces in low part divided into the lower turbinate. The middle turbinate, unlike others, a large number of blood vessels and nerves are distributed. Therefore, less hemorrhage might occurs when the tracheal tube enters into the lower pathway below the lower turbinate because the tube would not scratching the middle turbinate.

The hypothesis of this study is that the method 'sniffing position and nasal tip lifting' increases possibility to enter into lower pathway when the tube enters the nasal cavity. The purpose of a present study was to investigate the effect of 'sniffing position & nose' on the intranasal route of the tube.

Study Type

Interventional

Enrollment (Actual)

86

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 severe nasal deformities.
  • Who has a problem to make sniffing position or nasal tip lifting
  • Who has severe nasal bleeding history.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
Performed nasotracheal intubation as usual. Sniffing position but doesn't lift a nasal tip.
Procedure: Sniffing position
All procedure is done under sniffing position.
Experimental: Nasal tip lifting
Performed sniffing position and nasal tip lifting while the endotracheal tube insert patient's nasal cavity.
Procedure: Sniffing position
All procedure is done under sniffing position.
Procedure: Nasal tip lifting
Before inserting the endotracheal tube to patient's nose, the researcher lift up the nose tip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with nasal endotraheal tube in the lowest nasal pathway.
Time Frame: Through study completion, an average of 1 year
After the endotracheal intubation is completed, the experimenter confirms by a fiberoptic bronchoscope which path the endotracheal tube is located.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal bleeding
Time Frame: Through study completion, an average of 1 year
After nasotracheal intubation, the researcher confirm there is nasal bleeding or not. And if bleeding observed, the experimenter would check the amount.
Through study completion, an average of 1 year
Intubation time
Time Frame: Through study completion, an average of 1 year
Check the time from initiation of insertion of E-tube to finish passing nasal path and to finish intubation.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jung-Man Lee, M.D.,PhD, Seoul National University Boramae 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)

August 1, 2016

Primary Completion (Actual)

June 5, 2017

Study Completion (Actual)

July 21, 2017

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20160707/26-2016-90/072

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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