Clinical trial NCT04749225: Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation
Official title: Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intubation Complication
Keywords: video stylet
angulation
nasotracheal intubation
trachway
tracheal intubation
Endotracheal Tube intubation General Anesthesia (ETGA)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult(20-65 years old)

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: success rate of video stylet angulation and successful first tube attempt in 60 seconds
timeFrame: During procedure
measure: success rate of video stylet angulation and successful first tube attempt in Lung's ventilation
timeFrame: During procedure
measure: time taken advancement(TTI)
timeFrame: During procedure
measure: assessment of difficult intubation(IDS)
timeFrame: During procedure
measure: assessment of Glottic grade(Cormack Grade)
timeFrame: During procedure
Secondary outcomes:
measure: post-intubation induced oropharyngeal bleeding, hoarseness and sore throat
timeFrame: Day 2(the day after the operation)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin District
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Pin-Yang Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: