NCT03102255

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

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

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

March 20, 2017

Last Update Submit

October 12, 2017

Conditions

Intubation Complication

Keywords

Nasotracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Number of patients with nasal endotraheal tube in the lowest nasal pathway.

    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 Outcomes (2)

  • Nasal bleeding

    Through study completion, an average of 1 year

  • Intubation time

    Through study completion, an average of 1 year

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Performed nasotracheal intubation as usual. Sniffing position but doesn't lift a nasal tip.

Procedure: Sniffing position

Nasal tip lifting

EXPERIMENTAL

Performed sniffing position and nasal tip lifting while the endotracheal tube insert patient's nasal cavity.

Procedure: Sniffing positionProcedure: Nasal tip lifting

Interventions

Sniffing positionPROCEDURE

All procedure is done under sniffing position.

ConventionalNasal tip lifting
Nasal tip liftingPROCEDURE

Before inserting the endotracheal tube to patient's nose, the researcher lift up the nose tip.

Nasal tip lifting

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Hospital

Seoul, 07061, South Korea

Location

Related Publications (6)

  • Ahmed-Nusrath A, Tong JL, Smith JE. Pathways through the nose for nasal intubation: a comparison of three endotracheal tubes. Br J Anaesth. 2008 Feb;100(2):269-74. doi: 10.1093/bja/aem350. Epub 2007 Dec 14.

    PMID: 18083994BACKGROUND

  • Patiar S, Ho EC, Herdman RC. Partial middle turbinectomy by nasotracheal intubation. Ear Nose Throat J. 2006 Jun;85(6):380, 382-3.

    PMID: 16866113BACKGROUND

  • Williams AR, Burt N, Warren T. Accidental middle turbinectomy: a complication of nasal intubation. Anesthesiology. 1999 Jun;90(6):1782-4. doi: 10.1097/00000542-199906000-00039. No abstract available.

    PMID: 10360881BACKGROUND

  • Dost P, Armbruster W. Nasal turbinate dislocation caused by nasotracheal intubation. Acta Anaesthesiol Scand. 1997 Jun;41(6):795-6. doi: 10.1111/j.1399-6576.1997.tb04787.x.

    PMID: 9241346BACKGROUND

  • Scamman FL, Babin RW. An unusual complication of nasotracheal intubation. Anesthesiology. 1983 Oct;59(4):352-3. doi: 10.1097/00000542-198310000-00016. No abstract available.

    PMID: 6614546BACKGROUND

  • Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Choi S, Min SW. Influence of Nasal Tip Lifting on the Incidence of the Tracheal Tube Pathway Passing Through the Nostril During Nasotracheal Intubation: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1421-1426. doi: 10.1213/ANE.0000000000003673.

    PMID: 30044295DERIVED

Study Officials

  • Jung-Man Lee, M.D.,PhD

    Seoul National University Boramae Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 5, 2017

Study Start

August 1, 2016

Primary Completion

June 5, 2017

Study Completion

July 21, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)