video-stylet: Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03097913
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 32.9
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nasotracheal Intubation	Device: 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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Actual Study Start Date: Apr 5, 2017
• Anticipated Primary Completion Date: Aug 8, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
video-stylet tube assembly patients who undergo oxo-maxillofacial surgery with nasotracheal intubation general anesthesia are recruited	Device: video-stylet; recording each video-stylet endotracheal tube assembly advanced through the selected nasal cavity

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. postoperative nasal damages [24 hours]

   measurement of nasal bleeding and nasal congestion and nasal pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

• Study Director: kuang I Cheng, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03097913
• Other Study ID Numbers: KMUHIRB-E(II)_20160112
• First Posted: Mar 31, 2017
• Last Update Posted: Mar 20, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital: nasotracheal intubation; video-stylet; nasal cavity injury

Study Results

No Results Posted as of Mar 20, 2018