Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

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

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Pin-Yang Hu, MD.; Phone Number: 7035 88673121101; Email: u8901090@gmail.com
• Study Contact Backup: Name: Kuang-I Cheng, MD, PhD; Phone Number: 7035 88673121101; Email: kuaich@kmu.edu.tw

Study Locations

• Taiwan
  • Sanmin District
    • Kaohsiung, Sanmin District, Taiwan, 807
      • Recruiting
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Contact: Pin-Yang Hu, MD; Phone Number: 7035 88673121101; Email: u8901090@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult(20-65 years old)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
45° group; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of video stylet angulation and successful first tube attempt in 60 seconds	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.	During procedure
success rate of video stylet angulation and successful first tube attempt in Lung's ventilation	Lung's ventilation: The lung's ventilation is success.	During procedure
time taken advancement(TTI)	time taken advancement from nasal cavity into trachea in each time interval	During procedure
assessment of difficult intubation(IDS)	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".	During procedure
assessment of Glottic grade(Cormack Grade)	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	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-intubation induced oropharyngeal bleeding, hoarseness and sore throat	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.	Day 2(the day after the operation)

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Pin-Yang Hu, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: tracheal intubation; nasotracheal intubation; video stylet; Endotracheal Tube intubation General Anesthesia (ETGA); angulation; trachway
• Other Study ID Numbers: KMUHIRB-F(I)-20200202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No