Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient

Not Applicable

• Conditions: Anesthesia Intubation Complication
• Interventions: Device: fiberoptic bronchoscope; Device: video-stylet

• Registration Number: NCT01917435
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-07-10
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-04
• Last Update Submitted: 2013-08-04
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06
• Primary Completion: 2014-01
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring Nasotracheal Intubation under general anesthesia
4. limited mouth open ,mouth open < 3 cm
5. unlimited neck motion

Exclusion Criteria

1. Ankylosing arthritis patients.
2. BMI≧35 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fiberoptic bronchoscope	fiberoptic bronchoscope	Experimental: fiberoptic bronchoscope fiberoptic bronchoscope is used to facilitate for nasotracheal intubation.
video-stylet	video-stylet	Experimental: video-stylet video-stylet is used to facilitate for nasotracheal intubation.

Primary Outcome Measures

Name	Time	Method
number of the patients with successful nasotracheal intubation and scoring modified intubation difficulty scale	half an hour	Nasotracheal intubation is assisted by a video-stylet may be performed in patients undergoing Limited Mouth Opening following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg) and is facilitated by cis-atracurium 0.2 mg/kg administration. propofol 1 mg/kg intravenously to blunt hemodynamic responses while intubation.; a modified intubation difficulty scale to evaluate the difficulty of fiber-scope guided or trachway assisted nasotracheal intubation

Secondary Outcome Measures

Name	Time	Method
time to intubate	half an hour	time of Intubating the nasotracheal tube (NT) from selected nostril to trachea is continuously calculated but separately into two parts. part one: from leaving off mask ventilation (mask removal from face), to the NT tip on the nasopharynx. part two: advancing NT from nasopharynx, through vocal cord into trachea, to present of 3 end tidal carbon dioxide waveforms.

Trial Locations

Locations (1)

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