NCT03086798

Brief Summary

to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at 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

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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
9 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 7, 2023

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

February 1, 2017

Last Update Submit

November 5, 2023

Conditions

Nasotracheal Intubation

Keywords

Magill forcepscuff inflationNasotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • the technique spending time in this time interval and first attempt successful rate

    to measure the time taken of either using Magill forceps or with cuff inflation techniques in successfully intubated patients

    10 minutes

Secondary Outcomes (3)

  • total intubation time taken

    half an hour

  • glottic injury and cuff damages during tube advanced

    half an hour

  • postoperative nasal bleeding, sore throat and hoarseness

    2 days

Study Arms (2)

Magill forceps

EXPERIMENTAL

experimental Magill forceps group: Magill forceps technique to facilitate nasotracheal tube advancement into trachea

Procedure: Magill forceps

cuff inflation

EXPERIMENTAL

experimental cuff inflation group: cuff inflation technique to facilitate nasotracheal tube advancement into trachea

Procedure: cuff inflation

Interventions

Magill forcepsPROCEDURE

Magill forceps techniques to facilitate nasotracheal tube advancement into trachea

Magill forceps
cuff inflationPROCEDURE

cuff inflation techniques to facilitate nasotracheal tube advancement into trachea

cuff inflation

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
  • 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 City, 807, Taiwan

Location

Study Officials

  • Kuang I Cheng, MD, PhD

    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

February 1, 2017

First Posted

March 22, 2017

Study Start

March 31, 2017

Primary Completion

August 31, 2018

Study Completion

September 30, 2019

Last Updated

November 7, 2023

Record last verified: 2018-03

Locations

TW(1)