NCT03377114

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

December 13, 2017

Last Update Submit

September 14, 2018

Conditions

Intubation;Difficult

Keywords

Nasotracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Tube trapping

    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

Study Arms (2)

Neutral

ACTIVE COMPARATOR

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

Head tilting

EXPERIMENTAL

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

Interventions

NeutralPROCEDURE

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.

Neutral
Head tiltingPROCEDURE

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.

Head tilting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who need to nasotracheal intubation for surgery.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Hospital

Seoul, 07061, South Korea

Location

Related Publications (4)

  • 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. doi: 10.1093/bja/aeg203.

    PMID: 14504169BACKGROUND

  • 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.

    PMID: 18949966BACKGROUND

  • Ersoy B, Gursoy T, Celebiler O, Umuroglu T. A complication of nasotracheal intubation after mandibular subcondylar fracture. J Craniofac Surg. 2011 Jul;22(4):1527-9. doi: 10.1097/SCS.0b013e31821d4e04.

    PMID: 21778857BACKGROUND

  • Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.

    PMID: 31421677DERIVED

Study Officials

  • Jung-Man Lee, M.D.,PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 19, 2017

Study Start

December 14, 2017

Primary Completion

June 29, 2018

Study Completion

July 13, 2018

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations

KR(1)