Skip to content

Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation

Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735250
Enrollment
150
Registered
2021-02-03
Start date
2020-08-25
Completion date
2022-07-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Keywords

video stylet, angulation, orotracheal Intubation, trachway, tracheal intubation, Endotracheal Tube intubation General Anesthesia (ETGA)

Brief summary

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

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.

Interventions

None listed

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
success rate of video stylet angulation and successful first tube attempt in 60 secondsDuring proceduresuccessful 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 ventilationDuring proceduresuccessful 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 proceduretime taken advancement from oral cavity into trachea in each time interval
assessment of difficult intubation(IDS)During procedureAssessment 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 procedureAssessment 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

MeasureTime frameDescription
post-intubation induced oropharyngeal bleeding, hoarseness and sore throatDay 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.

Countries

Taiwan

Contacts

Primary ContactChia-Heng Lin, MD
linsofar@yahoo.com.tw88673121101
Backup ContactKuang-I Cheng, MD, PhD
kuaich@kmu.edu.tw88673121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026