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

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ClinicalTrials.gov Identifier: NCT03102255
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jung-Man Lee, Seoul National University Boramae Hospital

Brief Summary:

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?


Condition or disease Intervention/treatment Phase
Intubation Complication Procedure: Sniffing position Procedure: Nasal tip lifting Not Applicable

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  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of 'Sniffing Position & Nasal Tip Lifting' on the Pathway of Tracheal Tube in Nasal Cavity During Nasotracheal Intubation
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : July 21, 2017

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102255


Locations
Korea, Republic of
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 07061
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Jung-Man Lee, M.D.,PhD Seoul National University Boramae Hospital

Publications:
Responsible Party: Jung-Man Lee, Clinical Professor, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT03102255     History of Changes
Other Study ID Numbers: 20160707/26-2016-90/072
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung-Man Lee, Seoul National University Boramae Hospital:
Nasotracheal intubation