Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

Intubation Complication Clinical Trial

Official title:

Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749225
• Other study ID #: KMUHIRB-F(I)-20200202
• Status: Recruiting
• Start date: December 11, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Pin-Yang Hu, MD.
• Phone: 88673121101
• Email: u8901090[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• undergoing oro-maxillofacial surgery with general anesthesia(GA)

• ASA(American Society of Anesthesiologists):? 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

Related Conditions & MeSH terms

• Intubation Complication

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Sanmin District

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	time taken advancement(TTI)	time taken advancement from nasal cavity into trachea in each time interval	During procedure
Primary	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	During procedure
Primary	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	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)