Effect of Head Tilting During Nasotracheal Intubation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03377114
• Collaborator: SMG-SNU Boramae Medical Center (Other)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

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?

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult	Procedure: Neutral; Procedure: Head tilting	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: The Effect of Head Tilting on the Passing of Tracheal Tube Through Nasopharynx During Nasotracheal Intubation
• Actual Study Start Date: Dec 14, 2017
• Actual Primary Completion Date: Jun 29, 2018
• Actual Study Completion Date: Jul 13, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Tube trapping [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Boramae Hospital	Seoul		Korea, Republic of	07061

Sponsors and Collaborators

• Seoul National University Hospital
• SMG-SNU Boramae Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bozdogan N, Sener M, Yavuz H, Yilmazer C, Turkoz A, Arslan G. Retropharyngeal submucosal dissection due to nasotracheal intubation. B-ENT. 2008;4(3):179-81.
• Ersoy B, Gürsoy T, Celebiler O, Umuroğlu T. A complication of nasotracheal intubation after mandibular subcondylar fracture. J Craniofac Surg. 2011 Jul;22(4):1527-9. doi: 10.1097/SCS.0b013e31821d4e04.
• Paul M, Dueck M, Kampe S, Petzke F, Ladra A. Intracranial placement of a nasotracheal tube after transnasal trans-sphenoidal surgery. Br J Anaesth. 2003 Oct;91(4):601-4.

• Responsible Party: Jung-Man Lee, Clinical assistant professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03377114
• Other Study ID Numbers: 16-2017-64
• First Posted: Dec 19, 2017
• Last Update Posted: Sep 17, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jung-Man Lee, Clinical assistant professor, Seoul National University Hospital: Nasotracheal intubation

Study Results

No Results Posted as of Sep 17, 2018