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Video-stylet for Nasotracheal Intubation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01917409
Enrollment
100
Registered
2013-08-06
Start date
2012-12-31
Completion date
2014-03-31
Last updated
2013-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Difficult

Keywords

Conventional Laryngoscopy ,, Video-stylet ,, Nasotracheal Intubation

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.

Interventions

the device is to assist nasotracheal intubation

the device is to guide the nasotracheal tube into trachea

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
number of the patients with successful nasotracheal intubation and scoring difficult intubation scalehalf an hourNasotracheal 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)

Secondary

MeasureTime frameDescription
time to intubate10 minutestime 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.

Other

MeasureTime frameDescription
postoperative nasal bleeding, sore throat and hoarseness2 daysEvents 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

Countries

Taiwan

Contacts

Primary ContactKuang I Cheng, MD, PhD
kuaich@kmu.edu.tw073121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026