NCT02448277

Brief Summary

Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. The aim of the study is to compare the efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 22, 2017

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

May 15, 2015

Last Update Submit

March 20, 2017

Conditions

Keywords

Macintosh laryngoscope, Pentax, Glidescope

Outcome Measures

Primary Outcomes (1)

  • number of the patients with successful nasotracheal intubation and scoring difficult intubation scale

    Nasotracheal intubation assisted by a video-stylet may be performed in patients following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg, cis-atracurium 0.2 mg/kg and propofol 1 mg/kg)

    half an hour

Secondary Outcomes (1)

  • time to intubate

    10 minutes

Other Outcomes (1)

  • postoperative nasal bleeding, sore throat and hoarseness

    2 days

Study Arms (3)

Macintosh Laryngoscope

EXPERIMENTAL

experimental Macintosh Laryngoscope group: laryngoscope is used to assist for nasotracheal intubation.

Device: Macintosh Laryngoscope

Pentax Airway scope

EXPERIMENTAL

experimental Pentax Airway scope group:Pentax Airway scope is used to assist for nasotracheal intubation.

Device: Pentax Airway scope

Glidescope

EXPERIMENTAL

experimental Glidescope group:Glidescope is used to assist nasotracheal tube into trachea

Device: Glidescope

Interventions

the device is to assist nasotracheal intubation

Also known as: Macintoish laryngoscope
Macintosh Laryngoscope

the device is to assist the nasotracheal tube into trachea

Pentax Airway scope

the device is to assist the nasotracheal tube into trachea

Glidescope

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 Nasotracheal Intubation under general anesthesia

You may not qualify if:

  • mouth open \< 3 cm
  • limited neck extension \< 25 degree
  • 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 City, Kaohsiung, 807, Taiwan

Location

Study Officials

  • Kuang Yi Tseng, M.D.

    Department of anesthesiology, Kaohsiung Medical University, Taiwan

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2015

Last Updated

March 22, 2017

Record last verified: 2011-04

Locations