Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

• Conditions: Intubation Complication

• Registration Number: NCT04749225
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2020-12-11
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
success rate of video stylet angulation and successful first tube attempt in 60 seconds	During procedure	Time: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful.
success rate of video stylet angulation and successful first tube attempt in Lung's ventilation	During procedure	Lung's ventilation: The lung's ventilation is success.
assessment of difficult intubation(IDS)	During procedure	Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts\>1, score "N1"; Number of Operators \>1, score "N2"; Number of Alternative Techniques, score "N3"; Comark Grade -1, score "N4"; Lifting Force Required Normal, score "N5=0"; Lifting Force Required Increased, score "N5=1"; Laryngeal Pressure Not applied, score "N6=0"; Laryngeal Pressure Applied, score "N6=1"; Vocal Cord Mobility Abducion, score "N7=0"; Vocal Cord Mobility Adducion, score "N7=1". IDS=Sum of scores(N1-N7). If IDS score gains "0" means "Easy", "0\<IDS≤5" means "Slight Difficulty", "5\<IDS" means "Moderate to Major Difficulty", "IDS=∞" means "Impossible intubation".
time taken advancement(TTI)	During procedure	time taken advancement from nasal cavity into trachea in each time interval
assessment of Glottic grade(Cormack Grade)	During procedure	Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified

Secondary Outcome Measures

Name	Time	Method
post-intubation induced oropharyngeal bleeding, hoarseness and sore throat	Day 2(the day after the operation)	A visiting questionnaire is used to measure the condition of post-intubation, including oropharyngeal bleeding, sore throat, hoarseness, dysphagia. The score for the measurement of oropharyngeal bleeding, sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe. All the evaluation will be assessed in the next coming morning after the postoperation.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Sanmin District, Taiwan