Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient
Nasotracheal Intubation Assisted by a Video-stylet in Limited Mouth Opening Patient
1 other identifier
interventional
80
1 country
1
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.
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 Jan 2013
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
January 1, 2013
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
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 6, 2013
August 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 modified intubation difficulty scale
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
half an hour
Secondary Outcomes (1)
time to intubate
half an hour
Other Outcomes (1)
perioperative epistaxis, sore throat and hoarseness
2 days
Study Arms (2)
fiberoptic bronchoscope
EXPERIMENTALExperimental: fiberoptic bronchoscope fiberoptic bronchoscope is used to facilitate for nasotracheal intubation.
video-stylet
EXPERIMENTALExperimental: video-stylet video-stylet is used to facilitate for nasotracheal intubation.
Interventions
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
- limited mouth open ,mouth open \< 3 cm
- unlimited neck motion
You may not qualify if:
- 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
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
January 1, 2013
Primary Completion
January 1, 2014
Study Completion
June 1, 2014
Last Updated
August 6, 2013
Record last verified: 2013-08