Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04735250

Collaborator

(none)

150

Enrollment

Location

23.2

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication

Detailed Description

In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.

The advancement of the tube from oropharynx into trachea may assist using the video stylet.

The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.

Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal 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 oral 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation

Actual Study Start Date :

Aug 25, 2020

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
45° group Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the orotracheal tube passing the oral 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 orotracheal tube passing the oral 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 orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

Outcome Measures

Primary Outcome Measures

success rate of video stylet angulation and successful first tube attempt in 60 seconds [During procedure]
successful rate of the properly video stylet angulation passing through oral cavity into trachea. 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]
successful rate of the properly video stylet angulation passing through oral cavity into trachea. Lung's ventilation: The lung's ventilation is success.
time taken advancement(TTI) [During procedure]
time taken advancement from oral cavity into trachea in each time interval
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".
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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

undergoing surgery with general anesthesia(GA)
ASA(American Society of Anesthesiologists):Ι to III
20 to 65 years old
mouth Open > 3 cm
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, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth
morbid obesity
reject to participate