Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity

NCT ID: NCT03097913

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-05

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

we enrolled consecutive patients undergoing oxo-maxillofacial surgery by using video-stylet to establish airway and realize the tube angle changes while advancement, however, patients who did not inform or refuse to enroll into the study still use the video-stylet establish airway. the technique to use videostylet-tube assembly to establish airway is a commonly clinical practice in our hospital.

In general, the endotracheal tube goes through nasal cavity blindly either assist with traditional laryngoscope or video-laryngoscope. Tube advances through selected nasal cavity by using a video-stylet is able to prevent from damages of the abnormal turbinates and tissue mucosa. In addition, we are able to record the stylet angle into nostril, shift axis angle in nasal cavity to prevent orifice and side hole from damaging tissues while tube-stylet assembly advancement, and the angle ranges from initiate intubation to tube advanced into trachea.

the selected nostril is determined by Otolaryngologist who is not aware of the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasotracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

video-stylet tube assembly

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

video-stylet

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

video-stylet

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients undergo regular operation of oro-maxillofacial surgery

Exclusion Criteria

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

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

kuang I Cheng, MD, PhD

Role: STUDY_DIRECTOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25236899 (View on PubMed)

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.

Reference Type RESULT
PMID: 26460721 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMUHIRB-E(II)_20160112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.