Video-stylet for Nasotracheal Intubation

Intubation, Difficult Clinical Trial

Official title:

Comparison of Conventional Laryngoscopy and Video-stylet to Assist Nasotracheal Intubation for Patients Undergoing Oro-Maxillo-facial Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01917409
• Other study ID #: KMUH-IRB-20120320
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2013
• Last updated: August 4, 2013
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Kuang I Cheng, MD, PhD
• Phone: 073121101
• Email: kuaich[@]kmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare conventional laryngoscopy with video-stylet (Trachway) for nasotracheal intubation in patients undergoing oro-maxillo-facial surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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. unlimited mouth open

5. unlimited neck motion

Exclusion Criteria:

1. mouth open < 3 cm

2. Ankylosing arthritis patients.

3. BMI?35 kg/m2

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation, Difficult

Intervention

Device:
• conventional laryngoscopy
the device is to assist nasotracheal intubation
• video-stylet
the device is to guide the nasotracheal tube into trachea

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative nasal bleeding, sore throat and hoarseness	Events of intubating related nasal bleeding are recorded on selected nostril and oral cavity at 3 minutes post-intubation and post-operatively. Incidences of sore throat and hoarseness are evaluated before patients out of recovery room and the following morning	2 days	Yes
Primary	number of the patients with successful nasotracheal intubation and scoring difficult intubation scale	Nasotracheal intubation assisted by a video-stylet may be performed in patients undergoing oro-maxillo-facial surgery following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg, cis-atracurium 0.2 mg/kg and propofol 1 mg/kg)	half an hour	Yes
Secondary	time to intubate	time of Intubating the nasotracheal tube (NT) from selected nostril to trachea is continuously calculated but separately into two parts. part one: from termination of mask ventilation and mask removed 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.	10 minutes	Yes