NCT04087837

Brief Summary

either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

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

June 14, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

September 1, 2019

Last Update Submit

January 10, 2021

Conditions

Intubation Complication

Keywords

bougie, nasotracheal tubeEndotracheal Tube intubation General Anesthesia (ETGA)

Outcome Measures

Primary Outcomes (2)

  • success rate of tube advancement and successful first tube attempt

    success rate of tube passing through nasal cavity into trachea

    10 minutes

  • time taken in tube advancement

    time taken in tube advancement from nostril into trachea in each time interval

    10 minutes

Secondary Outcomes (1)

  • post-intubation induced hoarseness and sore throat

    2 days

Study Arms (3)

bougie group

EXPERIMENTAL

The bougie group: The end of the endotracheal tube was guided to the glottis using the endotracheal tube in the bougie mode under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.

Device: bougie

Nasogastric(NG) tube group

EXPERIMENTAL

NG tube group: The end of the endotracheal tube is guided to the glottis by using the endotracheal tube in the nasogastric tube under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.

Device: Nasogastric(NG) tube

control group

NO INTERVENTION

Control group: The general anesthesia method of placing the endotracheal tube through the nasal cavity is used to guide the tip of the endotracheal tube to the glottis under the direct view of the electronic imaging laryngoscope.

Interventions

bougieDEVICE

The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.

bougie group
Nasogastric(NG) tubeDEVICE

The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.

Nasogastric(NG) tube group

Eligibility Criteria

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

You may qualify if:

  • Age:20-65 years
  • Undergoing oro-maxillofacial surgery
  • Opening mouth \> 3 cm
  • Denied any systemic disease.
  • American Society of Anesthesiologists (ASA) class:I-III

You may not qualify if:

  • Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance \< 6cm)
  • Previous head and neck surgery history
  • Upper abnormal airway diagnosed
  • Easily epistaxis
  • Both sides nasal cavities obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: bougie or nasogastric tube
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

September 1, 2019

First Posted

September 12, 2019

Study Start

June 14, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

TW(1)