Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity

Completed

• Conditions: Nasotracheal Intubation
• Interventions: Device: video-stylet

• Registration Number: NCT03097913
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-02-28
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-26
• Study First Posted: 2017-03-31
• Study Start: 2017-04-05
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-31
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
video-stylet tube assembly	video-stylet	patients who undergo oxo-maxillofacial surgery with nasotracheal intubation general anesthesia are recruited

Primary Outcome Measures

Name	Time	Method
assessment nasal cavity and nasopharyngeal tissues damages	5-10 minutes	using video-stylet to safely navigate through selected nasal cavity and advancement into trachea

Secondary Outcome Measures

Name	Time	Method
video-stylet forward trend and angle changes during intubation	5-10 minutes	put tube-stylet assembly into selected nostril needs change the vectors while advancement
postoperative nasal damages	24 hours	measurement of nasal bleeding and nasal congestion and nasal pain

Trial Locations

Locations (1)

Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan