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Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

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ClinicalTrials.gov Identifier: NCT04749225
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pin-Yang Hu, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. success rate of video stylet angulation and successful first tube attempt in 60 seconds [ Time Frame: During procedure ]
    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.

  2. success rate of video stylet angulation and successful first tube attempt in Lung's ventilation [ Time Frame: During procedure ]
    Lung's ventilation: The lung's ventilation is success.

  3. time taken advancement(TTI) [ Time Frame: During procedure ]
    time taken advancement from nasal cavity into trachea in each time interval

  4. assessment of difficult intubation(IDS) [ Time Frame: 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".

  5. assessment of Glottic grade(Cormack Grade) [ Time Frame: 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 :
  1. post-intubation induced oropharyngeal bleeding, hoarseness and sore throat [ Time Frame: 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.


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult(20-65 years old)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749225


Contacts
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Contact: Pin-Yang Hu, MD. 88673121101 ext 7035 u8901090@gmail.com
Contact: Kuang-I Cheng, MD, PhD 88673121101 ext 7035 kuaich@kmu.edu.tw

Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Sanmin District, Taiwan, 807
Contact: Pin-Yang Hu, MD    88673121101 ext 7035    u8901090@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Pin-Yang Hu, MD Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information
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Responsible Party: Pin-Yang Hu, MD, Physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT04749225    
Other Study ID Numbers: KMUHIRB-F(I)-20200202
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pin-Yang Hu, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital:
video stylet
angulation
nasotracheal intubation
 trachway
tracheal intubation
Endotracheal Tube intubation General Anesthesia (ETGA)