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Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

K

Kaohsiung Medical University

Status

Enrolling

Conditions

Intubation Complication

Study type

Observational

Funder types

Other

Identifiers

NCT04749225
KMUHIRB-F(I)-20200202

Details and patient eligibility

About

Uses the video stylet with different angulation to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea.

Full description

In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages.

The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the nasotracheal tube passing the nasal cavity, oropharynx, and advanced into the tracheal. Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate nasotracheal tube sliding through into trachea and compared with each other group.

Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea will be recorded. The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.

Enrollment

150 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • undergoing oro-maxillofacial surgery with general anesthesia(GA)
  • ASA(American Society of Anesthesiologists):Ι to III
  • 20-65 y/o
  • mouth Open > 3cm
  • the systemic disease exclusion
  • conscious clear and without major Neurocognitive Disorder
  • Mandarin or Taiwanese speaker
  • agree the purpose of the study and sign the ICF

Exclusion criteria

  • difficult airway assessment [limited mouth opening<3cm, limited neck motion(thyromental distance < 6cm]
  • previous head neck surgery history
  • upper abnormal airway diagnosed, easily epistaxis, and both sides nasal cavities obstruction.
  • reject to participate

Trial design

150 participants in 3 patient groups

45° group
Description:
Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
70° group
Description:
Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
90° group
Description:
Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Trial contacts and locations

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Central trial contact

Pin-Yang Hu, MD.; Kuang-I Cheng, MD, PhD

Data sourced from clinicaltrials.gov

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