NCT03086668

Brief Summary

to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration 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

February 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
Last Updated

June 21, 2024

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

February 1, 2017

Last Update Submit

June 19, 2024

Conditions

Keywords

Nasotracheal Intubationjaw thrusthook-finger

Outcome Measures

Primary Outcomes (1)

  • grade of glottic field exposure and nasotracheal difficulty intubation score

    to compare the two different techniques in glottic field exposure and score of nasotracheal difficulty intubations scale

    half an hour

Secondary Outcomes (1)

  • the tube-videostylet assembly range of motion

    half an hour

Study Arms (2)

Conventional Jaw thrust Group

EXPERIMENTAL

an assembly of video-stylet and double curve endotracheal tube with conventional jaw thrust technique to facilitate nasotracheal intubation

Procedure: Conventional Jaw thrust Group

Fingers hook Group

EXPERIMENTAL

an assembly of video-stylet and double curve endotracheal tube with fingers-hook technique to facilitate nasotracheal intubation

Procedure: Fingers hook Group

Interventions

a video-stylet assisted nasotracheal intubation and facilitate by conventional jaw thrust technique

Conventional Jaw thrust Group

a video-stylet assisted nasotracheal intubation and facilitate by fingers-hook technique

Fingers hook Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with American Society of Anesthesiologists physical status I-III
  • aged 20-65 years
  • Requiring general anesthesia undergoing oxo-maxillofacial surgery
  • unlimited mouth open
  • unlimited neck motion

You may not qualify if:

  • mouth open \< 3 cm
  • Ankylosing arthritis patients.
  • BMI≧35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

  • Cheng KI, Yun MK, Chang MC, Lee KW, Huang SC, Tang CS, Chen CH. Fiberoptic bronchoscopic view change of laryngopharyngeal tissues by different airway supporting techniques: comparison of patients with and without open mouth limitation. J Clin Anesth. 2008 Dec;20(8):573-9. doi: 10.1016/j.jclinane.2008.01.013.

    PMID: 19100929BACKGROUND

Study Officials

  • Kuang I Cheng, MD, PhD

    Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University,Taiwan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

March 22, 2017

Study Start

March 27, 2017

Primary Completion

November 11, 2018

Study Completion

November 5, 2019

Last Updated

June 21, 2024

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations