Video-stylet for Nasotracheal Intubation
Comparison of Conventional Laryngoscopy and Video-stylet to Assist Nasotracheal Intubation for Patients Undergoing Oro-Maxillo-facial Surgery
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
August 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedAugust 6, 2013
July 1, 2013
1 year
July 10, 2013
August 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
time to intubate
10 minutes
Other Outcomes (1)
postoperative nasal bleeding, sore throat and hoarseness
2 days
Study Arms (2)
conventional laryngoscopy
EXPERIMENTALexperimental conventional laryngoscopy group: laryngoscope is used to assist for nasotracheal intubation.
video-stylet
EXPERIMENTALexperimental video-stylet group:video-stylet is used to guide nasotracheal tube into trachea
Interventions
the device is to assist nasotracheal intubation
the device is to guide the nasotracheal tube into trachea
Eligibility Criteria
You may qualify if:
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring Nasotracheal Intubation under general anesthesia
- unlimited mouth open
- unlimited neck motion
You may not qualify if:
- mouth open \< 3 cm
- Ankylosing arthritis patients.
- BMI≧35 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807, Taiwan
Related Publications (1)
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.
PMID: 25236899DERIVED
Study Officials
- STUDY DIRECTOR
Kuang I Cheng, MD., PhD.
Department of anesthesiology, Kaohsiung Medical University, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2013
First Posted
August 6, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
August 6, 2013
Record last verified: 2013-07