NCT03097913

Brief Summary

To investigate the double curve endotracheal tube safely navigate through nasal cavity under guidance of a video-stylet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

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 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

June 21, 2024

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

February 28, 2017

Last Update Submit

June 19, 2024

Conditions

Keywords

nasotracheal intubationvideo-styletnasal cavity injury

Outcome Measures

Primary Outcomes (1)

  • assessment nasal cavity and nasopharyngeal tissues damages

    using video-stylet to safely navigate through selected nasal cavity and advancement into trachea

    5-10 minutes

Secondary Outcomes (2)

  • video-stylet forward trend and angle changes during intubation

    5-10 minutes

  • postoperative nasal damages

    24 hours

Study Arms (1)

video-stylet tube assembly

patients who undergo oxo-maxillofacial surgery with nasotracheal intubation general anesthesia are recruited

Device: video-stylet

Interventions

recording each video-stylet endotracheal tube assembly advanced through the selected nasal cavity

video-stylet tube assembly

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing regular oro-maxillofacial surgery are included in the study from a medical university hospital (medical center)

You may qualify if:

  • patients undergo regular operation of oro-maxillofacial surgery

You may not qualify if:

  • easily nasal bleeding, mouth limited (opening mouth \< 3cm), hypertension, diabetes, chronic sinusitis with operative history, patients unwilling to be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kaohsiung City, Taiwan

Location

Related Publications (2)

  • Hsu HT, Lin CH, Tseng KY, Shen YC, Chen CH, Chuang WM, Cheng KI. Trachway in assistance of nasotracheal intubation with a preformed nasotracheal tube in patients undergoing oral maxillofacial surgery. Br J Anaesth. 2014 Oct;113(4):720-1. doi: 10.1093/bja/aeu334. No abstract available.

    PMID: 25236899BACKGROUND
  • Lee MC, Tseng KY, Shen YC, Lin CH, Hsu CW, Hsu HJ, Lu IC, Cheng KI. Nasotracheal intubation in patients with limited mouth opening: a comparison between fibreoptic intubation and the Trachway(R). Anaesthesia. 2016 Jan;71(1):31-8. doi: 10.1111/anae.13232. Epub 2015 Oct 12.

Study Officials

  • kuang I Cheng, MD, PhD

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 31, 2017

Study Start

April 5, 2017

Primary Completion

August 8, 2019

Study Completion

August 31, 2019

Last Updated

June 21, 2024

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations