Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

NCT04749225 | Unknown DMC

• 1 other identifier: KMUHIRB-F(I)-20200202
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation Complication

Keywords

video stylet; angulation; nasotracheal intubation; trachway; tracheal intubation; Endotracheal Tube intubation General Anesthesia (ETGA)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• post-intubation induced oropharyngeal bleeding, hoarseness and sore throat

  Day 2(the day after the operation)

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult(20-65 years old)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin District, 807, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

\*undergoing oro-maxillofacial surgery with general anesthesia(GA) \*ASA(American Society of Anesthesiologists):Ι to III -20 to 65 years old \*mouth open \> 3cm \*the systemic disease exclusion/conscious clear and without major Neurocognitive Disorder

Study Officials

• Pin-Yang Hu, MD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin-Yang Hu, MD.

CONTACT

88673121101; u8901090@gmail.com

Kuang-I Cheng, MD, PhD

CONTACT

88673121101; kuaich@kmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 11, 2021
• Study Start: December 11, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

TW (1)