NCT05112783

Brief Summary

Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 16, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 15, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

October 28, 2021

Last Update Submit

December 14, 2023

Conditions

Keywords

Endotracheal Tube intubation General Anesthesia (ETGA)nasotracheal tube

Outcome Measures

Primary Outcomes (2)

  • success rate

    success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea

    10 minutes

  • time

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

    10 minutes

Secondary Outcomes (1)

  • post-anesthesia care

    2 days

Study Arms (2)

Henan Tuoren Endotracheal Tube group

EXPERIMENTAL

Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Device: Henan Tuoren Endotracheal Tube

Smiths Portex Tracheal tubes group

EXPERIMENTAL

Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Device: Smiths Portex Tracheal Tubes

Interventions

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

Henan Tuoren Endotracheal Tube group

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

Smiths Portex Tracheal tubes 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)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin District, 807, Taiwan

RECRUITING

Study Officials

  • Pin-Yang Hu, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin-Yang Hu, MD

CONTACT

Kuang-I Cheng, PhD

CONTACT

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
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 9, 2021

Study Start

July 16, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

December 15, 2023

Record last verified: 2023-07

Locations